Reported Dec 26, 2012 · Terminated
SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for…
DePuy Orthopaedics, Inc.
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: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- SOL SYS F 9 CALC L 13.5MM
- LG PackagingProduct is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped
- Intended UseSOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components
- Lot codes and dates
- Product Code157226136
- and Lot codes
126676AB8GD1000AB8GDA000AF1EJ1000AF1EK1000AF1EKA000AF1EKB000AF7KF1000AT4GJ1000AT4GJA000AW8FX1000BR4KB1000C4VCSAC76FC1000C82MV1000D5LLL1000D6DE51ADG4FW1000E5RKD1E5RKDAE79KF1EJ4EJ1000and FH8H6A
- Amount recalled
- 1732 total all product codes
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
Why it was recalled
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a
This product could cause temporary or reversible health problems — stop using it.
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