Recall Z-1910-2012 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
DePuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product
| 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 | 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 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
| K972435 | ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM Johnson & Johnson Professionals, Inc., Sep 11, 1997 |