LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek liddi
FDA device recall Z-1922-2012 · posted 2012-06-29 · Terminated
Recall details
- Recalling firm
- DePuy Orthopaedics, Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- (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.
- Date initiated
- 2012-05-16
- Date posted
- 2012-06-29
- Date terminated
- 2013-03-05
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEPUY LUSTER STEM (K983136) | DePuy Orthopaedics, Inc. | 1998-11-25 |