FDA-Device2012-07-11Class II
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.
DePuy Orthopaedics, Inc.
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
Sold states
Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
Affected count
(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1917-2012Don't want to check this manually?
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