1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0
Summary
The FDA issued a Class II for 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 S by Howmedica Osteonics Corp.. Reason: 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 v.
Details
Source
Device Recall
External ID
Z-2640-2025
Action Date
2025-10-08
Status
Ongoing
Category
device
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;
Lot/Code Info: 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;
Quantity Affected: 55 units (all OUS)
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.
Distribution
International distribution in the country of United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-28
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Howmedica Osteonics Corp. has 113 FDA actions in our database, including 113 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Howmedica Osteonics Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Howmedica Osteonics Corp. have FDA actions?
Howmedica Osteonics Corp. has 113 FDA actions in our database, including 113 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2640-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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