—#109041

Product

LUSTER HIP SZ 1 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.

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K983136
Affected lot / code info: Product code: 152180001 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.

Timeline

Recall initiated: 2012-05-16
Posted by FDA: 2012-06-29
Terminated: 2013-03-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109041. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.