The Recall Desk
HighFDA (Devices)·Z-0829-2013·Announced 2013-02-27

DePuy LPS Diaphyseal Sleeves Recalled for Potential Taper Fracture

DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves because the taper connection may fracture under normal physiologic loads.

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 risk-of-harm product (potential fracture) where injury has not yet been reported, fitting the High severity criteria.

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 total units in the United States and 102 units outside the US. Distribution was worldwide, including nationwide in the US across 27 specific states and in the countries of Holland, Australia, Austria, South Africa, and Canada, including Veteran Administration hospitals. Affected part number is 198720020, 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

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 (20)

  • Part number: 198720020 and Lot numbers: 140576
  • 156212
  • 156213
  • 156214
  • 162644
  • 188411
  • 202954
  • 156214A
  • 202954A
  • B34GD1000
  • B4SBN1000
  • B4SBNA000
  • B4SBNB000
  • B4SBNC000
  • B5RAW1000
  • B5RAWA000
  • C3RHJ1000
  • C74JX1000
  • C74JXA
  • E18N61000

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 →

Related recalls

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · fracture

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