Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
FDA Recall Z-1524-2018 · Posted None
Recalling FirmZimmer GmbH
Recall StatusTerminated
Product CodeLZO
Date Initiated2018-02-28
Date Terminated2019-10-25
Reason for Recall
A potential commingle that could result in the product in the package not matching the product on the outer label.
Firm 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 [email protected].
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.
Root Cause
Error in labeling
Distribution Pattern
There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.