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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.

Valeant Pharmacueticals International

Class I - Dangerous

It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period.

Jan 29, 2016 Other Medical Devices Nationwide View Details →

Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600 4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001 4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200 4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600 4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000 4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500 4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000 4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500 4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000 4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601 4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801 4.5 mm Cortical Screw Self-Tapping, 20 mm Length 47484502001 4.5 mm Cortical Screw Self-Tapping, 22 mm Length 47484502201 4.5 mm Cortical Screw SelfTapping, 24 mm Length 47484502401 4.5 mm Cortical Screw SelfTapping, 26 mm Length 47484502601 4.5 mm Cortical Screw SelfTapping, 28 mm Length 47484502801 4.5 mm Cortical Screw SelfTapping, 34 mm Length 47484503401 4.5 mm Cortical Screw SelfTapping, 38 mm Length 47484503801 4.5 mm Cortical Screw SelfTapping, 40 mm Length 47484504001 4.5 mm Cortical Screw SelfTapping, 42 mm Length 47484504201 4.5 mm Cortical Screw SelfTapping, 54 mm Length 47484505401 4.5 mm Cortical Screw Self-Tapping, 58 mm Length 47484505801 4.5 mm Cortical Screw SelfTapping, 64 mm Length 47484506401 4.5 mm Cortical Screw SelfTapping, 66 mm Length 47484506601 4.5 mm Cortical Screw SelfTapping, 68 mm Length 47484506801 4.5 mm Cortical Screw SelfTapping, 70 mm Length 47484507001 6.5 mm Cancellous Screw Fully Threaded, 45 mm Length 47486504500 6.5 mm Cancellous Screw Fully Threaded, 55 mm Length 47486505500 6.5 mm Cancellous Screw Fully Threaded, 60 mm Length 47486506000 6.5 mm Cancellous Screw, 32 mm Thread Length, 60 mm Length 47486506002 6.5 mm Cancellous Screw Fully Threaded, 65 mm Length 47486506500 6.5 mm Cancellous Screw, 32 mm Thread Length, 65 mm Length 47486506502 6.5 mm Cancellous Screw Fully Threaded, 70 mm Length 47486507000 6.5 mm Cancellous Screw, 16 mm Thread Length, 80 mm Length 47486508001 6.5 mm Cancellous Screw, 32 mm Thread Length, 80 mm Length 47486508002 6.5 mm Cancellous Screw, 32 mm Thread Length, 85 mm Length 47486508502

Zimmer Manufacturing B.V.

Class I - Dangerous

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

May 4, 2016 Other Medical Devices Nationwide View Details →

Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560

Zimmer Manufacturing B.V.

Class I - Dangerous

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

May 4, 2016 Other Medical Devices Nationwide View Details →

Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401 3.5 mm Cortical Screw SelfTapping, 30 mm Length 47483503001 3.5 mm Cortical Screw SelfTapping, 40 mm Length 47483504001 3.5 mm Cortical Screw SelfTapping, 75 mm Length 47483507501

Zimmer Manufacturing B.V.

Class I - Dangerous

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

May 4, 2016 Other Medical Devices Nationwide View Details →

Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 24 mm Length 00114205124 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 28 mm Length 00114205128 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 30 mm Length 00114205130 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 38 mm Length 00114205138 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 48 mm Length 00114205148 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 65 mm Length 00114205165 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 55 mm Length 00114605599 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 60 mm Length 00114606099 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, 32 mm Thread Length, 7.0 mm Diameter, 65 mm Length 00114606532 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 65 mm Length 00114606599 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 12 mm Length 00114205012

Zimmer Manufacturing B.V.

Class I - Dangerous

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

May 4, 2016 Diagnostic Equipment Nationwide View Details →

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Biomerieux

Class I - Dangerous

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Feb 24, 2016 Diagnostic Equipment View Details →

Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

St Jude Medical

Class I - Dangerous

St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.

Mar 31, 2016 Implants & Prosthetics Nationwide View Details →