Recall Z-0083-2021
Biomet, Inc. · initiated September 4, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Codes / lots: 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…
Reason for recall
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
FDA-determined cause: Process change control
Action taken
Zimmer Biomet notified on 9/2/20 Distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory, as well as hospitals that have consumed products in the past 12 months will be notified via FedEx. Surgeons that have consumed products with in the past 12 months notified via FedEx. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you ha
Details
- Recall number
- Z-0083-2021
- Initiated
- September 4, 2020
- Terminated
- August 31, 2021
- Quantity
- US: 33 units; OUS: 269 units
- Distribution
- Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
- Recalling firm
- Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0081-2021 Class II | Biomet Regenerex Primary Taper Cap Item Number 141269Product not properly being aligned with the adequate gamma sterilization group and result in the product not… | 09/04/2020Terminated |
| Z-0082-2021 Class II | Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050Product not properly being aligned with the adequate gamma sterilization group and result in the product not… | 09/04/2020Terminated |
| Z-0084-2021 Class II | Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055Product not properly being aligned with the adequate gamma sterilization group and result in the product not… | 09/04/2020Terminated |