DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns
DePuy Orthopaedics is recalling Luster and Ultima LX hip stems implanted with metal-on-metal articulations due to a field safety notice.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (hip stem) with a potential for harm due to metal-on-metal articulation, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for LUSTER Cemented Polished Femoral Hip Stems and ULTIMA LX Cemented Polished Femoral Hip Stems. The recall involves stems that were implanted with any metal-on-metal (MoM) articulation, including configurations with a cobalt-chromium (CoCr) head and an all-metal acetabular cup (monoblock or modular).
The LUSTER Cemented Polished Femoral Hip Stems are forged CoCr polished cemented stems used as part of a total hip arthroplasty. They were indicated for use with all DePuy bearings and acetabular cups. The specific product code is 152180008, and the recall covers 85 units across 69 lots with specific lot numbers including A5BDJ1000, A73C51000, AH6D21000, X4GBW1000, and Z2YCR1000.
The products were distributed nationwide, including in California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin, and West Virginia. Patients who have had these specific hip stems implanted with metal-on-metal articulations should contact their healthcare provider for further evaluation and guidance.
The recalled product
- Product
- LUSTER HIP SZ 8 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
- Manufacturer
- DePuy Orthopaedics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product code:152180008 and Lot numbers: A5BDJ1000
- A73C51000
- AH6D21000
- X4GBW1000
- and Z2YCR1000.
Distribution
Part of a larger recall action
This product is one of 19 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Same hazard · metal on metal articulation
See all →- HighDePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
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