Agency classClass IOur severity:Severe FDA (Devices)·Z-0831-2013·Announced 2013-02-27

DePuy LPS Diaphyseal Sleeves Recalled for Potential Fracture Risk

DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves due to a potential fracture risk at the taper junction during normal gait activities.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device (potential fracture at the taper junction) which aligns with the rubric criterion for 'structural vehicle defect' or significant injury risk, warranting a Severe classification.

Plain-English summary

DePuy Orthopaedics, Inc. is initiating a voluntary recall of the LPS Diaphyseal Sleeves. These medical devices are used with the LPS System, an end-stage revision knee product designed to allow surgeons to reconstruct severe soft tissue and bony defects.

The recall is being conducted because the product has the potential for fracture at the taper junction. Specifically, the taper connection between the LPS Diaphyseal Sleeve and the Diaphyseal Sleeve Base may not be sufficient to accommodate potential physiologic loads transferred to the junction during normal gait activities by some patients.

The recall affects 162 units in the United States and 102 units outside the US. Distribution was worldwide, including nationwide distribution in the US across multiple states and in the countries of Holland, Australia, Austria, South Africa, and Canada, including Veteran Administration hospitals. Affected part number is 198720028, with specific lot numbers listed in the agency record.

The recalled product

Product: LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: fracture
structural-defect

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 (14)

Part number: 198720028 and Lot numbers: 123510
156211
212355
B34GG1000
B4TH51000
B5RAX1000
B5RAXA000
B5RAXB000
CC3KX1000
CC3KXA000
E4RF31000
E4RF3A000
E55HV1
and EN4KN1000.

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · fracture