Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1915-2012 — 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

U.S. FDA — Device Enforcement · United States · 2012-05-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1915-2012
Date of alert
2012-05-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DePuy Orthopaedics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
152180001
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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