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

Regenerex Primary Taper Cap recalled by Biomet

Biomet is recalling Biomet Regenerex Primary Taper Cap, 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: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610

Quantity recalledUS: 62 units; OUS: 176 units

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-0081-2021
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
Device type: Other Medical Devices

Timeline

4 Sep 2020	Recall initiated by company
8 Oct 2020	Classified by FDA	+34 days
14 Oct 2020	Published 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 Regenerex Primary Taper Cap Item Number 141269

Where it was distributed

Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM

Nationwide

Stores named: Walmart

Questions about this recall

Is Regenerex Primary Taper Cap recalled?

Yes. Biomet recalled Regenerex Primary Taper Cap on 4 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0081-2021.

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: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610

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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