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.
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 high-risk medical device configuration (metal-on-metal articulation) where injury has not yet been explicitly reported in the 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 LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems. The notice applies to these specific stems when they 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 ULTIMA LX Cemented Polished Femoral Hip Stems are forged CoCr polished cemented stems used as part of a total hip arthroplasty. The product was packaged in PETG blister trays with Tyvek lids and foam protectors. The recall involves 431 units across 78 lots, with specific product code 853151 and lot numbers 438748, 438877, 475209, XBG33, XED09, and YFE44.
Distribution was nationwide, including 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/SZ2 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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