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
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 is classified as FDA Class II and involves a risk-of-harm product (metal-on-metal articulation) where specific injury reports are not detailed in the provided source text, fitting the High severity criteria.
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. The recall specifically affects units that 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 affected products are forged CoCr polished cemented stems used as part of a total hip arthroplasty. The ULTIMA LX stems 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, with product code 853156 and specific lot numbers including 438753, 438882, 633709, 577070U, XBK75, XCE41, XCU45, XFE22, XHL11, and XHL12.
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 stems implanted with metal-on-metal articulations should contact their healthcare provider for further evaluation and guidance.
The recalled product
- Product
- ULTIMA*LX STM,POL 10/12TAP/1M 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 (10)
- Product code: 853156 and Lot numbers: 438753
- 438882
- 633709
- 577070U
- XBK75
- XCE41
- XCU45
- XFE22
- XHL11
- and XHL12
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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