CLASS II Device recall · Reported 14 Oct 2020 · FDA Enforcement Report

Arthrosimplicity Kit Eu recalled by Biomet

Biomet is recalling Biomet Arthrosimplicity KIT EU, distributed nationwide in the US. The recall was initiated on 4 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 894660A 894660B 894670B 894700B
Quantity recalled4 units 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-0084-2021
FDA event ID
86424
Recalling firm
Biomet, Warsaw, IN
Classification
Class II
Status
Terminated
Recall initiated
4 Sep 2020
FDA classified
8 Oct 2020
Reported
14 Oct 2020
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

4 Sep 2020Recall initiated by company
8 Oct 2020Classified by FDA+34 days
14 Oct 2020Published in enforcement report+6 days

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

Reason for recall

Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055

Where it was distributed

Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM

Nationwide

Stores named: Walmart

Questions about this recall

Is Arthrosimplicity Kit Eu recalled?

Yes. Biomet recalled Arthrosimplicity Kit Eu on 4 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0084-2021.

Why was it recalled?

Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

Which lots are affected?

Lot Numbers: 894660A 894660B 894670B 894700B

Where was it sold?

Nationwide Foreign: Canada, FINLAND, NETHERLANDS, 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 21 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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