DePuy Recalls Cemented Polished Femoral Hip Stems Implanted with Metal-on-Metal Articulations
DePuy Orthopaedics is issuing a Field Safety Notice for LUSTER and ULTIMA LX Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
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 implant) where the hazard is the use of a specific articulation type (metal-on-metal), but the source text does not report specific injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
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 notice applies to these specific stems when they 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 ULTIMA LX Cemented Polished Femoral Hip Stems are forged CoCr polished cemented stems used as part of a total hip arthroplasty. The recall involves 431 units across 78 lots. 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 to discuss the Field Safety Notice and determine if any further action is required.
The recalled product
- Product
- ULTIMA*LX STM,POL 10/12TAP/3M 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…
- 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 (10)
- Product code: 853158 and Lot numbers: 550633
- 642337
- XDG35
- XDG36
- XED10
- XFE24
- XHL14
- XHL15
- YAX31
- and YGN25.
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.
See all 19 products in this recall →Related recalls
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Same hazard · metal on metal articulation
See all →- HighDePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
FDA (Devices) · 2012-07-11
- HighDePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal Articulations
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- HighDePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns
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- HighDePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
FDA (Devices) · 2012-07-11
- HighDePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Use
FDA (Devices) · 2012-07-11
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