Reported May 24, 2017 · Terminated
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Zimmer Biomet, 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 Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 00-5988-020-14— — 00889024221475Lot Number: 63463357, Description: NexGen Offset Stem Ext Size 14, UDI: (01)00889024221475(17)260930(10)63463357 00-5988-020-17— — 00889024221505Lot Number: 63463367, Description: (01)00889024221505(17)260930(10)63463367, Manufactured Date: 9/19/2016, Expiration Date: 9/30/2026 - Amount recalled
- 24
Where it was sold
Why it was recalled
Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
This product could cause temporary or reversible health problems — stop using it.
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