FDAClass IIOctober 8, 2025

1. Exeter V40 Stem 44mm NO 2 recall

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;

Why was 1. Exeter V40 Stem 44mm NO 2 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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;

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;
Recalling firm
Howmedica Osteonics Corp.
Quantity
55 units (all OUS)
Distribution
International distribution in the country of United Kingdom.
Recall date
October 8, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls