DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is recalling ULTIMA LX and LUSTER cemented polished femoral hip stems implanted with metal-on-metal articulations due to a field safety notice.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device (metal-on-metal articulation) that poses a significant risk of 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 recall involves 431 ULTIMA LX Cemented Polished Femoral Hip Stems across 78 lots. The affected products are forged CoCr polished cemented stems used as part of a total hip arthroplasty.
The recall is triggered by the implantation of these stems with any metal-on-metal (MoM) articulation, including configurations with a CoCr head and an all-metal acetabular cup. 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 for evaluation. The recall is classified as Class II by the FDA.
The recalled product
- Product
- ULTIMA*LX STM,POL 10/12TAP/4M 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 was
- 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 (7)
- Product code: 853159 and Lot numbers: 438756
- 438885
- 577073
- 633711
- 660443
- 663756
- and XCE43.
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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