Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint… — Class II medical device recall Z-2292-2016
Terminated recall by Zimmer Gmbh, reported 2016-08-03, distributed nationwide. Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿l
| Recall number | Z-2292-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Gmbh, Winterthur, N/A, Switzerland |
| Recall initiated | 2016-06-30 |
| Classified | 2016-07-26 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2017-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Lot numbers | 4022860, 4023094 |
| Model numbers | 01.06010.004, 01.06010.106 |
Product
Avenir M¿ller Stem 4 Standard Avenir M¿ller 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.
Reason for recall
Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2292-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.