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Howmedica Osteonics - safety alert

Official notice

8 Oct 2025

MediumFDA

An official FDA notice concerns Howmedica Osteonics. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-10-08. Lots: A00976, G8754849, may. Models: 0580-1-442, 0580-1-352. Recall numbers: Z-2640-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

55

Recall number

Z-2640-2025

Official notice

2025-10-08

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

A00976, G8754849, may

Skus

0580-1-442, 0580-1-352

Other

UDI-DI 04546540153319, UDI-DI 04546540153241

Event Ids

97559

Model Numbers

0580-1-442, 0580-1-352

Recall Numbers

Z-2640-2025

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

GB · United Kingdom

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Howmedica Osteonics. Contact: Howmedica Osteonics Corp..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-2640-2025

Event id

97559

Units affected

55

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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