Reported Oct 8, 2025 · Ongoing
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number:…
Howmedica Osteonics Corp.
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: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- 1. EXETER V40 STEM 44MM NO 2
- Model/Catalog Number
0580-1-4422. EXETER V40 STEM 37.5MM NO 0
- Model/Catalog Number0580-1-352
- Lot codes and dates
- 1
- Model/Catalog Number0580-1-442
- UDI-DI04546540153319
- Lot Number
A009762
- Model/Catalog Number0580-1-352
- UDI-DI04546540153241
- Lot NumberG8754849
- Amount recalled
- 55 units (all OUS)
Why it was recalled
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
This product could cause temporary or reversible health problems — stop using it.
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