Recall Z-1917-2012 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
DePuy Orthopaedics, Inc.
LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use wi
| Date | Jun 29, 2012 (initiated May 16, 2012) |
| Status | Terminated |
| Reason | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U |
| Root cause | Device Design |
| Action | DePuy sent an "URGENT RECALL INFORMATION-FIELD SAFETY NOTICE" letter dated May 16, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 574-372-7333 for questions regarding this notice. |
| Quantity | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots |
| Distribution | Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983136 | DEPUY LUSTER STEM DePuy Orthopaedics, Inc., Nov 25, 1998 |