CLASS II ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report

Exeter V40 Stem No recalled by Howmedica Osteonics

Howmedica Osteonics is recalling Exeter V40 Stem No 2. The recall was initiated on 28 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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 recalled55 units (all OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2640-2025
FDA event ID: 97559
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 28 Aug 2025
FDA classified: 26 Sep 2025
Reported: 8 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

28 Aug 2025	Recall initiated by company
26 Sep 2025	Classified by FDA	+29 days
8 Oct 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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;

Where it was distributed

International distribution in the country of United Kingdom.

Questions about this recall

Why was it 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.

Which lots 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;

Where was it sold?

International distribution in the country of United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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