FDAFDA · Food and drugs·Recall number Z-1917-2012
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 with all DePuy bearings and acetabular cups.
Published July 11, 2012 · Recall initiated: May 16, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
- Lot
- Product code:152180003 and Lot numbers: A46D71000, A52C11000, A88D11000, AY2CE1000, B1XGV1000, BA3BF1000, BC6BC1000, BX9B71000, Y97FM1000, and Z5NBJ1000.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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