DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is recalling ULTIMA LX and LUSTER hip stems implanted with metal-on-metal articulations due to potential safety concerns.
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 Class II medical device with a risk of harm (metal-on-metal articulation) where specific injury reports are not detailed in the provided source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems. This recall involves 431 ULTIMA LX stems across 78 lots that were implanted with any metal-on-metal (MoM) articulation, including configurations with a cobalt-chromium (CoCr) head and an all-metal acetabular cup.
The affected products were distributed nationwide, including in California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin, and West Virginia. The stems are forged CoCr polished cemented stems used as part of a total hip arthroplasty.
Patients who have had these specific hip stems implanted with metal-on-metal articulations should contact their healthcare provider to discuss the recall and potential next steps.
The recalled product
- Product
- ULTIMA*LX STM,POL 10/12TAP/SZ1 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 wa
- 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 (6)
- Product code: 853151and Lot numbers: 438748
- 438877
- 475209
- XBG33
- XED09
- and YFE44.
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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