DePuy Luster and Ultima Hip Stems Recalled for Metal-on-Metal Use
DePuy Orthopaedics is recalling Luster and Ultima hip stems implanted with metal-on-metal articulations due to a field safety notice.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 specific contraindication (metal-on-metal articulation) that poses a risk of harm, 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 applies to these stems when they were implanted with any metal-on-metal (MoM) articulation, which includes a head of CoCr and an acetabular cup of all-metal construction (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 are indicated for use with all DePuy bearings and acetabular cups. The specific product code is 152180010, and the affected lot numbers are A4VCY1000 and T76A61007.
The affected 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 10 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…
- 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 (1)
- Product code:152180010 and Lot numbers: A4VCY1000 and T76A61007.
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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See all →- HighDePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
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