FDA-Device2025-10-08Class II
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;
Howmedica Osteonics Corp.
Hazard
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.
Sold states
International distribution in the country of United Kingdom.
Affected count
55 units (all OUS)
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2640-2025Don't want to check this manually?
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