Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496

FDA Recall Z-1525-2018 · 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.

K123392AVENIR MULLER STEMZimmer GmbH · 2013-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑