FDA Device recall Z-0576-2013
SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points by Depuy Orthopaedics, citing 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 hea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0576-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-03 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
SOL SYS 8IN CALC 1.5/16.5 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
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
Identifiers
| code_info | Product Code: 157215165 and Lot codes: 111621, FG9KT1, 126365, X3VB41000, A19GL1000, X4SC51000, A3XF31000, X4SC5A000, A…Product Code: 157215165 and Lot codes: 111621, FG9KT1, 126365, X3VB41000, A19GL1000, X4SC51000, A3XF31000, X4SC5A000, A3XF3A000, X4SC61000, A63GR1000, X53B11000, A6AE81000, X5REA1000, A6AE8A000, YF4AX1000, AY7KN1000, YF4AXA000, AY7KNA000, YG2CY1000, B19CJ1000, Z41AT1000, B3BJV1000, Z6BB91000, B3CAX1000, Z83BA1000, B65DF1000, Z83BAB000, B65DFA000, ZL9FW1000, C1YLX1000, ZL9FWA000, C34B81000, C34B8A000, C4JCR1000, C4JCRA000, C4VCR1000, C4VCRA000, CB2K71000, CH7ED1000, CK3EX1000, D32J61000, D46LG1000, D6DDD1000, D88H81000, DA2EN1000, DD3BS1000, DD3BSA000, DG1PA1000, DS7KC1000, E1KJ91000, E3SDG1000, E56BX1000, E5EB31000, FB3E31, FB8P91, FE9P41, and FG9KS1. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0576-2013%22
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