MedWorm: Medical Equipment Alerts

Biomet, Inc. - Phoenix Retrograde Femoral Nail - Class 2 Recall

Medical Device Recalls — Sun, 16 Jun 2013 01:00:05 +0100

Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. (Source: Medical Device Recalls)

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Zimmer, Inc. - Zimmer Patient Helper Bed Frame Adapter Assembly - Class 2 Recall

Medical Device Recalls — Sat, 15 Jun 2013 01:00:07 +0100

Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress. (Source: Medical Device Recalls)

Ormco/Sybronendo - SybronEndo Replacement AC Power Cord, US Elements Obturation; - Class 2 Recall

Medical Device Recalls — Sat, 15 Jun 2013 01:00:07 +0100

SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment. (Source: Medical Device Recalls)

Ormco/Sybronendo - SybronEndo Elements Obturation Unit; - Class 2 Recall

Medical Device Recalls — Sat, 15 Jun 2013 01:00:07 +0100

SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment. (Source: Medical Device Recalls)

Edwards Lifesciences, LLC - QuickDraw Venous Cannula - Class 2 Recall

Medical Device Recalls — Fri, 14 Jun 2013 01:00:12 +0100

QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona¿ pyrogenic in a sealed, peel-type pouch. (Source: Medical Device Recalls)

Abbott Medical Optics, Inc. - STAR S4 IR Excimer System (STAR S4 IR) - Class 2 Recall

Medical Device Recalls — Fri, 14 Jun 2013 01:00:12 +0100

STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. (Source: Medical Device Recalls)

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Abbott Medical Optics, Inc. - STAR S3 ActiveTrack Excimer System (STAR S3) - Class 2 Recall

Medical Device Recalls — Fri, 14 Jun 2013 01:00:12 +0100

STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. (Source: Medical Device Recalls)

Abbott Medical Optics, Inc. - STAR S4 with Variable Spot Scanning Excimer System (STAR S4) - Class 2 Recall

Medical Device Recalls — Fri, 14 Jun 2013 01:00:12 +0100

STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. (Source: Medical Device Recalls)

Utah Medical Products, Inc - Deltran Kit - Class 2 Recall

Medical Device Recalls — Fri, 14 Jun 2013 01:00:08 +0100

Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals. (Source: Medical Device Recalls)

OrthoPediatrics Corp - OrthoPediatrics PediLoc Locking Cannulated Blade Plate System - Class 2 Recall

Medical Device Recalls — Thu, 13 Jun 2013 01:00:12 +0100

90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies. (Source: Medical Device Recalls)

Bard Peripheral Vascular Inc - PTA Balloon Dilatation Catheters - Class 2 Recall

Medical Device Recalls — Thu, 13 Jun 2013 01:00:07 +0100

BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess¿ PTA Balloon Dilatation Catheters are supplied sterile and intended for single use. (Source: Medical Device Recalls)

Embla System Llc - Embletta Gold - Class 2 Recall

Medical Device Recalls — Wed, 12 Jun 2013 01:00:11 +0100

embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals of a sleeping patient. Item Numbers: RMIV003465 RMIV017570 RMRE008075 UI009108 UI010814 UI013848 RMIV019053 RMIV019328 RMIV019340 RMIV019634 RMIV020254 1010005552 1010005585 1010002453 1010001588 135150668 1010003915 1010002669 RMIV019542 1010002370 UI018933 RMIV019638 RMIV019850 RMIV020166 UI012625...

Ethicon Endo-Surgery Inc - ECHELON 60mm Endoscopic Linear Cutter Reloads Black - Class 2 Recall

Medical Device Recalls — Wed, 12 Jun 2013 01:00:09 +0100

ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the relo...

International Biomedical, Ltd. - VIA Medical Collection Bag - Class 2 Recall

Medical Device Recalls — Wed, 12 Jun 2013 01:00:08 +0100

VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102). (Source: Medical Device Recalls)

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Bard Peripheral Vascular Inc - MICROSHEATH 0.066 (1.7mm) proximal, 0.064 (1.6mm); - Class 2 Recall

Medical Device Recalls — Tue, 11 Jun 2013 01:00:16 +0100

MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085. The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath¿ is a single lumen catheter that has a 123cm working length and a straight tip shape (Source: Medical Device Recalls)

Bard Peripheral Vascular Inc - USHER Support Catheter Angled Tip WL130cm - Class 2 Recall

Medical Device Recalls — Tue, 11 Jun 2013 01:00:16 +0100

USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher¿ Peripheral is a single lumen support catheter, with a standard luer fitting at the proximal end. The Usher¿ Peripheral is available in a length 130 cm with an angled tip shape. (Source: Medical Device Recalls)

Bard Peripheral Vascular Inc - BARD Biopsy Systems - Class 2 Recall

Medical Device Recalls — Tue, 11 Jun 2013 01:00:16 +0100

BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA). (Source: Medical Device Recalls)

Bard Peripheral Vascular Inc - UltraClip Dual Trigger breast tissue marker - Class 2 Recall

Medical Device Recalls — Sun, 09 Jun 2013 01:00:09 +0100

BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy. (Source: Medical Device Recalls)

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Fenwal Inc - AMICUS Exchange Kit - Class 2 Recall

Medical Device Recalls — Sun, 09 Jun 2013 01:00:08 +0100

AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path. (Source: Medical Device Recalls)

Siemens Healthcare Diagnostics, Inc. - MicroScan Dried Negative Breakpoint Combo - Class 2 Recall

Medical Device Recalls — Sun, 09 Jun 2013 01:00:07 +0100

Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility. (Source: Medical Device Recalls)

American Optisurgical Inc - TX1 Tissue Removal System - Class 2 Recall

Medical Device Recalls — Sat, 08 Jun 2013 01:00:09 +0100

TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery. (Source: Medical Device Recalls)

Applied Medical Resources Corp - Epix and Direct Drive Laparoscopic Graspers - Class 2 Recall

Medical Device Recalls — Sat, 08 Jun 2013 01:00:09 +0100

Applied Medical s Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery. (Source: Medical Device Recalls)

DePuy Orthopaedics, Inc. - Glenosphere Orientation Guide for the Delta XTEND Reverse Shoulder System - Class 2 Recall

Medical Device Recalls — Sat, 08 Jun 2013 01:00:08 +0100

DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere. (Source: Medical Device Recalls)

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Dental EZ Stardental Division - StarDental Classique(TM) Diamond Dental Bur - Class 2 Recall

Medical Device Recalls — Sat, 08 Jun 2013 01:00:08 +0100

StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures. (Source: Medical Device Recalls)

Endologix Inc - Catheter, Introducer - Class 1 Recall

Medical Device Recalls — Sat, 08 Jun 2013 01:00:07 +0100

Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction. (Source: Medical Device Recalls)

Invatec Llc - lnvatec SpA brand Diver C.E - Class 2 Recall

Medical Device Recalls — Sat, 08 Jun 2013 01:00:06 +0100

lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. (Source: Medical Device Recalls)

Siemens Healthcare Diagnostics, Inc - Siemens ADVIA Centaur iPTH Calibrator - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:11 +0100

ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays. (Source: Medical Device Recalls)

Siemens Healthcare Diagnostics, Inc - Siemens ADVIA Centaur iPTH ReadyPack Assay - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:11 +0100

ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). (Source: Medical Device Recalls)

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Siemens Healthcare Diagnostics, Inc - Siemens ADVIA Centaur iPTH Calibrator - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:11 +0100

ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays. (Source: Medical Device Recalls)

Siemens Healthcare Diagnostics, Inc - Siemens ADVIA Centaur iPTH ReadyPack Assay - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:11 +0100

ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). (Source: Medical Device Recalls)

Symbios Medical Products, LLC - GOPump - Class 1 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:10 +0100

Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP, 2.5" fenestrated catheter & BIOPATCH Go Pump Kit 510141-BP,10" fenestrated catheter& BIOPATCH Disposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. (Source: Medical Device Recalls)

Symbios Medical Products, LLC - GOBlock - Class 1 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:10 +0100

Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery (Source: Medical Device Recalls)

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Symbios Medical Products, LLC - GOPump - Class 1 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:10 +0100

Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epidural catheter & BIOPATCH GoPump Kit 510204, 2.5" Fenestrated catheter GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch GoPump Kit 510205BP, 5" Fenestrated catheter & Biopatch GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch GoBlock kit 510608 Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. (Source: Medical Device Recalls)

Symbios Medical Products, LLC - GOBlock - Class 1 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:10 +0100

Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system. (Source: Medical Device Recalls)

Symbios Medical Products, LLC - GOPump - Class 1 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:10 +0100

Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. (Source: Medical Device Recalls)

Symbios Medical Products, LLC - GOBlock - Class 1 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:10 +0100

Symbios Medical Products, LLC - GOPump - Class 1 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:10 +0100

Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. (Source: Medical Device Recalls)

Cordis Corporation - FLEXSTENT Biliary SelfExpanding Stent System (US Commercial 80 cm Length) - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:09 +0100

FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. (Source: Medical Device Recalls)

Cordis Corporation - FLEXSTENT Femoropopliteal SelfExpanding Stent System (Clinical Study Protocol FSS0003 (OPEN trial) - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:09 +0100

FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions. (Source: Medical Device Recalls)

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Cordis Corporation - FLEXSTENT Biliary SelfExpanding Stent System (US Commercial 120 cm Length) - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:09 +0100

Cordis Corporation - FLEXSTENT Femoropopliteal SelfExpanding Stent System (EU Commercial 120 cm Length) - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:09 +0100

AGFA Corp. - DXD 100 MOBILE DR - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:09 +0100

AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. (Source: Medical Device Recalls)

Cordis Corporation - FLEXSTENT Femoropopliteal SelfExpanding Stent System (EU Commercial 80 cm Length) - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:09 +0100

Alcon Grieshaber AG - Constellation Vision System Pneumatic Handpiece - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:08 +0100

The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery. (Source: Medical Device Recalls)

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Berchtold Corp. - OPERON Hand Controls for Operon D750, D752, D760, D820 and D850 - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:08 +0100

Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables (Source: Medical Device Recalls)

Stryker Instruments Div. of Stryker Corporation - Hytrel Toga - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:05 +0100

Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. (Source: Medical Device Recalls)

American Optisurgical Inc - FAST Procedure Kit - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:05 +0100

FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. (Source: Medical Device Recalls)

Stryker Instruments Div. of Stryker Corporation - Hytrel Toga - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:05 +0100

Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. (Source: Medical Device Recalls)

American Optisurgical Inc - TX1 Tissue Removal System - Class 2 Recall

Medical Device Recalls — Fri, 07 Jun 2013 01:00:04 +0100

American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. (Source: Medical Device Recalls)

Intuitive Surgical, Inc. - da Vinci 5 mm Flared Instrument Cannulae - Class 2 Recall

Medical Device Recalls — Thu, 06 Jun 2013 01:00:11 +0100

da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments (Source: Medical Device Recalls)

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SpineFrontier, Inc. - Dorado Straight Impactor - Class 2 Recall

Medical Device Recalls — Thu, 06 Jun 2013 01:00:11 +0100

Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices. (Source: Medical Device Recalls)

Coloplast Manufacturing US, LLC - Digitex 20 Polydioxanone (PDO) suture - Class 2 Recall

Medical Device Recalls — Thu, 06 Jun 2013 01:00:11 +0100

Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture. (Source: Medical Device Recalls)

Kreg Medical Inc. - EZ Wider Bariatric Bed - Class 2 Recall

Medical Device Recalls — Thu, 06 Jun 2013 01:00:11 +0100

E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology (Source: Medical Device Recalls)

Intuitive Surgical, Inc. - da Vinci 5 mm Instrument Cannulae - Class 2 Recall

Medical Device Recalls — Thu, 06 Jun 2013 01:00:11 +0100

da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments, (Source: Medical Device Recalls)