DePuy Recalls Cemented Polished Femoral Hip Stems Due to Metal-on-Metal Use
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 medical device (Class II) with a potential risk of harm related to metal-on-metal articulations, 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 the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems. This notice applies to these specific stems 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 are indicated for use with all DePuy bearings and acetabular cups. The product was packaged in PETG blister trays with Tyvek lids and foam protectors. The recall involves 431 units across 78 lots, with product code 853157 and specific lot numbers including 475235, 639640, and others.
Distribution was nationwide, including California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin, and West Virginia. The source text does not specify reported illnesses or injuries, nor does it provide specific instructions for consumers beyond the issuance of the Field Safety Notice.
The recalled product
- Product
- ULTIMA*LX STM,POL 10/12TAP/2M 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 (16)
- Product code: 853157 and Lot numbers: 475235
- 639640
- 640919
- 662465
- XBK76
- XCE42
- XCU47
- XEW27
- XFE23
- XFX43
- XHL13
- YAX30
- YDW82
- YEK32
- YFE46
- and YKK07.
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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