ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged… — recall Z-1906-2012
U.S. FDA — Device Enforcement · United States · 2012-05-16 · Class II
As described by U.S. FDA — Device Enforcement: ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
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
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