Z-1524-2018Class II

Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10)...

Name: Z-1524-2018 Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10)...
Creator: Zimmer GmbH
Published: 2018-02-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-02-28 / Terminated / root cause: labeling and UDI

FDA source

Zimmer GmbH began a recall of Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368 on 2018-02-28. FDA classified it as Class II and gives the reason as "A potential commingle that could result in the product in the package not matching the product on the outer label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1524-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-28
Posted: 2018-04-26
Terminated: 2019-10-25
Recalling firm: Zimmer GmbH
Product: Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: A potential commingle that could result in the product in the package not matching the product on the outer label.
Root cause tag: labeling and UDI
FDA 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 [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.
Distribution: There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.
Product codes and lots: Lot Number: 2904368

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1524-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1524-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26
Z-1525-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26

Product code LZO

K123392Class IIAvenir Muller StemZimmer GmbH / cleared 2013-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)