Recall Z-1525-2018 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer GmbH
Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
| Date | Feb 28, 2018 |
| Status | Terminated |
| Reason | A potential commingle that could result in the product in the package not matching the product on the outer label. |
| Root cause | Error in labeling |
| Action | 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 Ac |
| Distribution | There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123392 | AVENIR MULLER STEM Zimmer GmbH, Mar 4, 2013 |