DePuy Orthopaedics, Inc. Recall: SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed wi
DePuy Orthopaedics, Inc. Recall: SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed wi is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: DePuy Orthopaedics, Inc.; Product: SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed
| Recalling firm | DePuy Orthopaedics, Inc. |
|---|---|
| Product | SOL SYS 8IN CALC 1.5/18.0 Packaging: Product 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 Use: SOLUTION 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 |
| Reason for recall | 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR |
| Recall initiated | 20121203 |
| Recall number | Z-0577-2013 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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