Recall Z-1524-2018
Zimmer GmbH · initiated February 28, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
Codes / lots: Lot Number: 2904368
Reason for recall
A potential commingle that could result in the product in the package not matching the product on the outer label.
FDA-determined cause: Error in labeling
Action taken
On March 7, 2018 Field Safety Corrective Action Notices were hand delivered by Zimmer Biomet team members or their representatives. Customers were instructed to complete the following: 1.Review this notification for awareness of the contents. 2.Assist your Zimmer Biomet sales representative to quarantine immediately all affected implants. 3.Your Zimmer Biomet sales representative will remove the affected implants from your facility. 4.Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy to fieldaction.emea@zimmerbiomet.com. b. Retain a copy of the Certificate of Acknowledgement with your field action records in the event of a compliance audit of your documentation. 5.If after reviewing the notice you have further questions or concerns please contact your Zimmer Biomet representative.
Details
- Recall number
- Z-1524-2018
- Initiated
- February 28, 2018
- Terminated
- October 25, 2019
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Distribution
- There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.
- Recalling firm
- Zimmer GmbH, Winterthur
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1525-2018 Class II | Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI:…A potential commingle that could result in the product in the package not matching the product on the outer… | 02/28/2018Terminated |