1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Mod
Pending LLM rewrite. Source: FDA_DEVICE Z-2640-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 1. Model/Catalog Number: 0580-1-442
- UDI-DI: 04546540153319
- Lot Number: A00976
- 2. Model/Catalog Number: 0580-1-352
- UDI-DI: 04546540153241
- Lot Number: G8754849
Distribution
Distribution scope not specified by the agency.
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