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Recall Observatory FDA recall evidence

Device 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.

Z-1915-2012

May 16, 2012

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 61749
Status
Terminated
Classification
Class II
Quantity
(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Official record key
device-enforcement:Z-1915-2012

Official wording

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

Code information: Product code: 152180001 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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