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;
Reported: October 8, 2025 Initiated: August 28, 2025 #Z-2640-2025
Product Description
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;
Reason for Recall
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.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 55 units (all OUS)
- Distribution
- International distribution in the country of United Kingdom.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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;. Recalled by Howmedica Osteonics Corp.. Units affected: 55 units (all OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 8, 2025. Severity: Moderate. Recall number: Z-2640-2025.
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