Reported Apr 1, 2015 · Terminated
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage:…
Zimmer Trabecular Metal Technology, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Trabecular Metal Technology, Inc. · 10 Pomeroy Rd · Parsippany, NJ · 07054-3722
Is this the product you have?
- NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only
- Product UsageIntended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use
- Lot codes and dates
20 MM - Part No. 00-5490-034-24Lot #613574282T 5 MM - Part No. 00549003410Lot #61357484T
- Amount recalled
- 1 unit
Where it was sold
Why it was recalled
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
This product could cause temporary or reversible health problems — stop using it.
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