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

OnPoint Scope Procedure Kit recalled by Biomet

Biomet is recalling Biomet OnPoint Scope Procedure Kit, 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: 868570A 868670A 869650A 869710B 869770A 880720B 926610B 941910A 868570B 868670B 869650B 869720A 869770B 880730A 926620A 941910B 868590A 868680A 869660A 869720B 869780B 880730B 926620B 941920A 868610A 868680B 869660B 869730A 869790B 926570A 926630A 941920B 868610B 868690A 869680B 869730B 880610B 926570B 926630B 941930B 868640A 868690B 869690A 869740A 880700A 926580B 926640A 942010B 868650A 868700A 869690B 869740B 880710A 926590A 926640B 942030B 868650B 868700B 869700A 869750A 880710B 926600A 941900A 942040A 868660A 868710A 869700B 869750B 880720A 926610A 941900B 942040B 868660B 868710B 869710A 869760B

Quantity recalled80 units US

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-0082-2021
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 OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050

Where it was distributed

Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM

Nationwide

Stores named: Walmart

Questions about this recall

Is OnPoint Scope Procedure Kit recalled?

Yes. Biomet recalled OnPoint Scope Procedure Kit on 4 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0082-2021.

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: 868570A 868670A 869650A 869710B 869770A 880720B 926610B 941910A 868570B 868670B 869650B 869720A 869770B 880730A 926620A 941910B 868590A 868680A 869660A 869720B 869780B 880730B 926620B 941920A 868610A 868680B 869660B 869730A 869790B 926570A 926630A 941920B 868610B 868690A 869680B 869730B 880610B 926570B 926630B 941930B 868640A 868690B 869690A 869740A 880700A 926580B 926640A 942010B 868650A 868700A 869690B 869740B 880710A 926590A 926640B 942030B 868650B 868700B 869700A 869750A 880710B 926600A 941900A 942040A 868660A 868710A 869700B 869750B 880720A 926610A 941900B 942040B 868660B 868710B 869710A 869760B

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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