1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, ...
FDA Recall #Z-2640-2025 — Class II — August 28, 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.
Recalling Firm
Howmedica Osteonics Corp. — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
55 units (all OUS)
Distribution
International distribution in the country of United Kingdom.
Code Information
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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated