The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1919-2012·Announced 2012-07-11

DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal Components

DePuy Orthopaedics issued a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 (implanted hip stem) with a potential for harm, but the source text does not report specific injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for LUSTER Cemented Polished Femoral Hip Stems and 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. This includes configurations using a cobalt-chromium (CoCr) head and an acetabular cup made of all-metal construction, whether monoblock or modular.

The LUSTER stems are forged CoCr polished cemented stems used as part of a total hip arthroplasty. They are indicated for use with all DePuy bearings and acetabular cups. The recall involves 85 LUSTER Cemented Polished Femoral Hip Stems across 69 lots. The specific product code is 152180005, and the lot numbers are AH7DVA000 and VJ3B21003.

The affected products were distributed nationwide, including in California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin, and West Virginia. The source text does not specify the exact number of patients affected or report any specific injuries or illnesses. Patients who have had these specific hip stems implanted with metal-on-metal components should contact their healthcare provider for further evaluation.

The recalled product

Product
LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
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 (1)

  • Product code:152180005 and Lot numbers: AH7DVA000 and VJ3B21003.

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.

See all →

Same hazard · metal on metal wear

See all →

Similar recalls