Reported Feb 28, 2018 · Terminated
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee…
Zimmer Orthopedic Mfg Ltd.
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 ORTHOPEDIC MFG LTD · Building No 2 East Park · Shannon, N/A · N/A
Is this the product you have?
- NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
- Lot codes and dates
- Item Number00-5964-017-51
- Lot Numbers (UDI Number)63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)
- Amount recalled
- 7 devices
Where it was sold
Why it was recalled
There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
This product could cause temporary or reversible health problems — stop using it.
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