The Recall Desk
HighFDA (Devices)·Z-1910-2012·Announced 2012-07-11

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 (hip implant) with a specific articulation configuration (metal-on-metal) that poses a risk of harm, but the source text does not report specific injuries, illnesses, or fatalities, nor does it explicitly classify the recall as FDA Class I.

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 stem products 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 recall involves 431 units of the ULTIMA LX stems across 78 lots. 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 further evaluation and guidance.

The recalled product

Product
ULTIMA*LX STM,POL 10/12TAP/SZ5 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.
Category
Medical Device — Orthopedic Implants
Hazard

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 (4)

  • Product code: 853155 and Lot numbers: 438752
  • 475234
  • 633707
  • and XBK74.

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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.

See all 19 products in this recall →

Related recalls

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · metal on metal wear

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