Reported Jul 11, 2012 · Terminated
ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- ULTIMA*LX STM
- POL 10/12TAP/SZ5 PackagingThe 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 UseThe 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
- Lot codes and dates
- Product code853155
- and Lot numbers
438752475234633707and XBK74
- Amount recalled
- 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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