Howmedica Osteonics Corp.: Medical Device Recall in 2025 - (Recall #: Z-2640-2025)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2025.
Data Source: FDA.
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;
Product Classification:
Class II
Date Initiated: August 28, 2025
Date Posted: October 8, 2025
Recall Number: Z-2640-2025
Event ID: 97559
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.
Status: Ongoing
Product Quantity: 55 units (all OUS)
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;
Distribution Pattern:
International distribution in the country of United Kingdom.
Voluntary or Mandated:
Voluntary: Firm initiated