Recall Z-1923-2012— DePuy Orthopaedics, Inc.

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2012-05-16, terminated 2013-03-05. FDA's recall record names no specific 510(k) clearance for this event. Product: LUSTER HIP SZ 9 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.. 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.

Recalling firm

DePuy Orthopaedics, Inc.

Classification

Class II

Status

Terminated

Initiated

2012-05-16

Terminated

2013-03-05

Firm location

Warsaw, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.