Z-2292-2016Class II

Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained...

Name: Z-2292-2016 Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained...
Creator: Zimmer Gmbh
Published: 2016-06-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-06-30 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Gmbh began a recall of Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended... on 2016-06-30. FDA classified it as Class II and gives the reason as "Product mix-up. The Avenir Mller Stem 6 lateral uncemented might be placed in the packaging of the Avenir Mller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of...". 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-2292-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-30
Posted: 2016-07-26
Terminated: 2017-03-27
Recalling firm: Zimmer GmbH
Product: Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Product mix-up. The Avenir Mller Stem 6 lateral uncemented might be placed in the packaging of the Avenir Mller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 30, 2016 to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification immediately and ensure affected personnel are aware of the contents and assist Zimmer Biomet sales representative with the quarantine of any affected device. Your Zimmer Biomet sales representative will remove any affected device. Customers were also instructed to complete the Certification of Acknowledgement form and return to [email protected]. Customers with further questions or concerns were instructed to contact the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST. For questions regarding this recall call 800-348-2759.
Quantity in commerce: 2
Distribution: Nationwide Distribution to OH and NM
Product codes and lots: Item Name: Avenir M¿ller Stem 4 Standard Item Number: 01.06010.004 Lot Number: 4022860 Item Name: Avenir M¿ller Stem 6 Lateral Item Number: 01.06010.106 Lot Number: 4023094

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2292-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2292-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-26

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)