The Recall Desk
Severity pendingFDA (Devices)·Z-2640-2025·Announced 2025-10-08

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.

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.