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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Detail

Product Description ULTIMA*LX STM,POL 10/12TAP/SZ2 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 a carton and shrink wrapped. Intended Use: The ULTIMA LX 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.
Recall Number Z-1907-2012
Classification Class II
Code Info Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.
Product Distributed Qty 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Reason For Recall 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.

Event Detail

Event Id 61749
Product Type Devices
Status Ongoing
Recalling Firm DePuy Orthopaedics, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
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