SOL SYS L 9IN CALC 2 — Class II medical device recall Z-0582-2013
Terminated recall by DePuy Orthopaedics, Inc., reported 2012-12-26, distributed nationwide. An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement wit
| Recall number | Z-0582-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-12-03 |
| Classified | 2012-12-20 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,732 all |
| Lot numbers | B19HN1000, B19HNA000, B3FAF1000, BF6A21000, C32GEA, C5PRY1000, C61CD1000, CD1EW1000, EE5K61000, X33GC1000, X49FV1000, X4KF91000, X4KGA1000, X4KGB1000, X5SB41000, X5SB4A000, X5SB4B000, X5SB4C000, Y14GJ1000, Y14GJA000, YD3H31000, YD3HY1000, YG8B11000, YH9E21000, YH9E2B000 |
Product
SOL SYS L 9IN CALC 2.25/18 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 sufficient sound bone to seat and support the components.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0582-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.