Biomet ONPOINT SCOPE PROCEDURE KIT-EU: Risk of improper sterilization
Biomet recalls ONPOINT SCOPE PROCEDURE KIT-EU (item 24-3055) due to potential improper sterilization. Affected units have specific lot numbers; consumers should check their product.
Lower-risk recall
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Contact the company
What happened, in plain English
Biomet is recalling its ONPOINT SCOPE PROCEDURE KIT-EU (item 24-3055) because the product may not be properly sterilized during gamma sterilization. This could lead to contamination risks if used in medical procedures. Read more at govinfonow.com/recall/64374-biomet-onpoint-scope-procedure-kit-eu-risk-of-improper-sterilization.
Source Summary by GovInfoNow · govinfonow.com/recall/64374-biomet-onpoint-scope-procedure-kit-eu-risk-of-improper-sterilization · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0083-2021
Cite this page
“Biomet ONPOINT SCOPE PROCEDURE KIT-EU: Risk of improper sterilization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64374-biomet-onpoint-scope-procedure-kit-eu-risk-of-improper-sterilization. Based on FDA recall #Z-0083-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0083-2021%22&limit=1).
Why it’s dangerous
The product may not be properly sterilized during gamma sterilization, which could lead to contamination if used in medical procedures. This is a risk during the sterilization process but not a direct hazard in normal use.
Who’s affected
Medical professionals using the ONPOINT SCOPE PROCEDURE KIT-EU for surgical procedures are most at risk. The recall affects specific lot numbers of this kit.
How to tell if you have this one
Check the item number (24-3055) and lot numbers listed in the recall notice. The affected kits have specific lot numbers starting with 866270A through 947040B.
- Brand
Biomet- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0081-2021 | Biomet Regenerex Primary Taper Cap Item Number 141269; Lot Numbers: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610 | US: 62 units; OUS: 176 units |
| Z-0082-2021 | Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050; 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 | 80 units US |
| Z-0083-2021 | Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055; Lot Numbers: 866270A 887060B 919100B 938510A 942310A 905460A 907080A 930110A 866270B 887070A 919110A 938510B 942310B 905460B 907080B 930110B 866280A 887070B 919110B 938520A 942320A 905470A 907090A 930120A 866280B 887080A 919120A 938520B 942320B 905470B 907090B 930120B 866290A 887080B 919120B 938530A 942330A 905480A 907100A 930130A 866290B 887090A 919130A 938530B 942330B 905480B 907100B 930130B 866300A 887090B 919130B 938540A 942340B 905490A 907110A 930140A 866300B 887100A 920410A 938540B 946900A 905490B 907110B 930140B 866310A 887100B 920410B 942150A 946900B 905500A 907120A 934570A 866310B 902920A 920420A 942150B 946910A 905500B 907120B 934570B 866320A 902920B 920420B 942160A 946910B 905520A 907130A 934580A 866320B 902930A 920430A 942160B 946930B 905520B 926660A 934580B 866330A 907130B 920430B 942180A 946940A 905530A 926660B 934590A 866330B 915230A 920440A 942180B 946950B 905530B 926670A 934590B 876100A 915230B 920440B 942190A 946960A 905540A 926670B 934600A 876100B 915240A 920450A 942190B 946960B 905540B 926680A 934600B 876110A 915240B 920450B 942200A 946980B 905550A 926680B 934610A 876110B 915250A 920460A 942200B 947010B 905550B 926690A 934610B 876120A 915250B 920460B 942210A 947020A 905560A 926690B 936120A 876120B 915260A 922170A 942210B 947020B 905560B 926700A 936120B 876130A 915260B 922170B 942220A 947030A 905640A 926700B 936130A 876130B 915270A 922180A 942220B 947030B 905640B 926710A 936130B 876140A 915270B 922180B 942230A 947040A 905650A 926710B 936140A 876140B 915280A 922190A 942230B 947040B 905650B 926720A 936140B 876150A 915280B 922190B 942240A 902930B 905660A 926720B 936150A 876150B 917710A 922200A 942240B 902940A 905660B 928920A 936150B 876160A 917710B 922200B 942250A 902940B 905670A 928920B 936160A 876160B 917720A 922210A 942250B 902950B 905670B 928930A 936160B 887010A 917720B 922210B 942260A 902960A 905680A 928930B 936170A 887010B 917730A 922220A 942260B 902960B 905680B 928940A 936170B 887020A 917730B 922220B 942270A 902970A 907040A 928940B 936180A 887020B 917740A 922230A 942270B 902970B 907040B 928950A 936180B 887030A 917740B 922230B 942280A 902980A 907050A 928950B 936190A 887030B 917750A 922240A 942280B 902980B 907050B 928960A 936190B 887040A 917750B 922240B 942290A 902990A 907060A 928960B 938490A 887040B 919090A 926650A 942290B 903000A 907060B 930100A 938490B 887050A 919090B 926650B 942300A 903010A 907070A 930100B 938500A 887050B 919100A 938500B 942300B 903010B 907070B | US: 33 units; OUS: 269 units |
| Z-0084-2021 | Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055; Lot Numbers: 894660A 894660B 894670B 894700B | 4 units OUS |
What to do — step by step
Check Product Lot Number
Look for the lot number on the kit packaging or label to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall states the product may not be properly sterilized, so it is not safe to use until the recall is addressed.
What should I do if I have this product?
Check the lot number against the list provided in the recall notice to see if it is affected.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0083-2021 (September 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0083-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.