Medical Devices Recalls

90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF AE56/STR GRN 14MM, Rx, Sterile; 90597004117 Articular Surface CR ART SURF AE56/STR GRN 17MM, Rx, Sterile; 90597004120 Articular Surface CR ART SURF AE56/STR GRN 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.

Getinge USA

Class I - Dangerous

AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters.

Aug 2, 2013 Diagnostic Equipment View Details →

90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM, Rx, Sterile; 90597002017 Articular Surface CR ART SURF 12/PURPLE 17MM, Rx, Sterile; 90597002020 Articular Surface CR ART SURF 12/PURPLE 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.

Gyrus Medical

Class I - Dangerous

On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.

Jul 24, 2013 Surgical Instruments Nationwide View Details →

00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Femur CR PRC FEM COMP SIZE DML Rx, Sterile; 00597001404 Femur CR PRC FEM COMP SIZE DMR Rx, Sterile; 00597001503 Femur CR PRC FEM COMP SIZE EML Rx, Sterile; 00597001504 Femur CR PRC FEM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.

GE Healthcare

Class I - Dangerous

GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and

May 2, 2013 Other Medical Devices Nationwide View Details →

00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Sterile; 00597103114 Provisional CR ART SURF PROV 34/STR YEL 14, Rx, Sterile; 00597103117 Provisional CR ART SURF PROV 34/STR YEL 17, Rx, Sterile; 00597103120 Provisional CR ART SURF PROV 34/STR YEL 20, Rx, Sterile; 00597103123 Provisional CR ART SURF PROV 34/STR YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile; 00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14, Rx, Sterile; 00595204117 Articular Surface XLPE CR ART SURF 5-6/STRGRN 17, Rx, Sterile; 00595204120 Articular Surface XLPE CR ART SURF 5-6/STRGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF 1,2/PUR 17, Rx, Sterile; 00595202020 Articular Surface XLPE CR ART SURF 1,2/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597003117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597003120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597003123 Articular Surface CR ART SURF 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx, Sterile; 00597001533 Femur CR PRC SURF HDN FEM CO-NID EML Rx, Sterile; 00597001534 Femur CR PRC SURF HDN FEM CO-NID EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533 Femur CR POR SURF HDN FEM CO-NID EML, Rx, Sterile; 00597201534 Femur CR POR SURF HDN FEM CO-NID EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.

Endogastric Solutions

Class I - Dangerous

Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention was necessary to remove the device.

Jun 6, 2013 Other Medical Devices Nationwide View Details →

ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.

Convatec

Class I - Dangerous

ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.

Jun 25, 2013 Other Medical Devices Nationwide View Details →

00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597104120 Provisional CR ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597104123 Provisional CR ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597504112 Provisional AC ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597504114 Provisional AC ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597504117 Provisional AC ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597504120 Provisional AC ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597504123 Provisional AC ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →

00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, Rx, Sterile; 00595203114 Articular Surface XLPE CR ART SURF 3,4/SYEL 14, Rx, Sterile; 00595203117 Articular Surface XLPE CR ART SURF 3,4/SYEL 17, Rx, Sterile; 00595203120 Articular Surface XLPE CR ART SURF 3,4/SYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

Zimmer

Class I - Dangerous

Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

Jun 7, 2013 Implants & Prosthetics Nationwide View Details →