Recall Z-0081-2021
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 Regenerex Primary Taper Cap Item Number 141269
Codes / lots: Lot Numbers: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610
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-0081-2021
- Initiated
- September 4, 2020
- Terminated
- August 31, 2021
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Quantity
- US: 62 units; OUS: 176 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-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-0083-2021 Class II | Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055Product 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 |