FDA Device recall Z-2292-2016
Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemente…
- FDA Device
- Class II
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class II recall of Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemente… by Zimmer, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2292-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-30 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer |
| Distribution | US |
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
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.
Identifiers
| code_info | Item Name: Avenir M¿ller Stem 4 Standard Item Number: 01.06010.004 Lot Number: 4022860 Item Name: Avenir M¿ller St…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2292-2016%22
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