Zimmer NexGen Knee Implant Recall Lawsuit - Recalled Parts & Lot Codes

PRODUCT
1) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution, Femoral and Provisional Impactor/Extractor, REF 00-5901-026-00. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

2) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Posterior Referencing Sizer, REF 00-5901-040-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

3) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Posterior Referencing Sizer Boom, REF 00-5901-040-10, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

4) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Patella Peg Drill Guide Handle, REF 00-5903-060-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

5) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Quick-Connect Handle, REF 00-5901-034-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

6) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Modular T-Handle, REF 00-5901-061-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

7) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Extramedullary Distal Telescoping Tube, REF 00-5901-071-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

8) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Extramedullary Proximal Telescping Rod, REF 00-5901-072-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

9) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Extramedullary Modular Spike Arm Post, REF 00-5901-074-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

10) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Distal Femoral Resection Guide, REF 00-5901-063-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

11) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Femoral Valgus Alignment Guide, REF 00-5901-067-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

12) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Patella Clamp, REF 00-5901-067-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

13) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution Patella Osteotomy Guide, REF 00-5903-010-00, Nonsterile. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
CODE
1) Lots: 61516146, 61522231, 61542077, 61550613, 61565681, 61584069, 61584438, 61594876, 61610343, 61637191, 61657309, 61659596, 61675231, 61691488, 61701224 and 61708918;

2) Lots: 61510769, 61558673, 61584439, 61584919 and 61610687;

3) Lots: 61505400, 61558201, 61570225, 61574608, 61580669, 61585371 and 61594877;

4) Lots: 61511575, 61532582, 61539020, 61542246, 61554844, 61580690, 61610344, 61630733 and 61509149;

5) Lots: 61501824, 61542065, 61550601, 61575890, 61585376, 61612789, 61615894, 61626378, 61634995, 61635431, 61648520, 61657310, 61660292, 61675232 and 61682485;

6) Lots: 61491168, 61517185, 61580671, 61609572, 61635436, 61655095 and 61658440;

7) Lots: 61515856, 61559187, 61581693, 61582497, 61593950, 61610647, 61633778, 61635523, 61637140 and 61659209;

8) Lots: 61495957, 61543636, 61583135 and 61586295;

9) Lots: 61488062, 61549223, 61584526, 61593951, 61516298 and 61517186;

10) Lots: 61511564, 61548704, 61583731, 61586294, 61608148, 61610172, 61615895, 61632405, 61635449, 61658442, and 61673283;

11) Lots: 61516151, 61517153, 61559529, 61585375, 61587424, 61603824, 61610584, 61610623, 61625078, 61628952, 61635427, 61635428, 61655097 and 61658448;

12) Lots: 61516147, 61554517, 61555948, 61587399, 61610586, 61635432, 61652932 and 61658455;

13) Lots: 61510164 and 61559367
RECALLING FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN,
REASONnThe firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
VOLUME OF PRODUCT IN COMMERCE 6,026 units
DISTRIBUTION Nationwide, Australia, Canada, Germany, Japan, New Delphi and Singapore