Reported Aug 3, 2016 · Terminated
Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or…
Zimmer GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Gmbh · Sulzer Allee 8 · Winterthur, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
- Item NameAvenir M¿ller
- Stem 4 Standard Item Number01.06010.004
- Lot Number4022860
- Item NameAvenir M¿ller
- Stem 6 Lateral Item Number01.06010.106
- Lot Number4023094
- Amount recalled
- 2
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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