Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ULTIMA*LX STM Recalled by DePuy Orthopaedics, Inc. Due to DePuy Orthopaedics, Inc. is issuing a Field Safety...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Orthopaedics, Inc. directly.
Affected Products
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.
Quantity: 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc. has 154 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report