Enforcement Report - Week of July 11, 2012
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Product Detail
| Product Description | LUSTER HIP SZ 2 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. |
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| Recall Number | Z-1916-2012 |
| Classification | Class II |
| Code Info | Product code:152180002 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000. |
| Product Distributed Qty | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 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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