DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER 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 Class II medical device with a potential risk of harm (metal-on-metal articulation) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
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. This notice applies to these specific stem products when they were implanted with any metal-on-metal (MoM) articulation. This includes configurations using a cobalt-chromium (CoCr) head and an acetabular cup of all-metal construction, whether 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. They were indicated for use with all DePuy bearings and acetabular cups. The recall involves 431 ULTIMA LX Cemented Polished Femoral Hip Stems across 78 lots. The products were distributed nationwide, including in California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin, and West Virginia.
The source text does not specify the exact action required for patients or healthcare providers beyond the issuance of the Field Safety Notice. It does not report any specific injuries, illnesses, or deaths associated with these devices.
The recalled product
- Product
- ULTIMA*LX STM,POL 10/12TAP/SZ3 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 (9)
- Product code: 853153 and Lot numbers: 438750
- 604146
- 660441
- 0858531531
- XCU42
- XFE20
- YAX29
- YCT82
- and YEG20.
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
FDA (Devices) · 2012-07-11
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