device · product 1 of 1
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.
- Recall number
- Z-2292-2016
- Initiated
- June 30, 2016
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Zimmer Gmbh
- Quantity
- 2
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Labeling mix-ups
Inspect official wording and provenance
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.
Code information
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
Distribution pattern
Nationwide Distribution to OH and NM