The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0830-2013·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 gait loads.

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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be…"

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 help surgeons 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 and in the countries of Holland, Australia, Austria, South Africa, and Canada. Healthcare providers and patients should contact DePuy Orthopaedics or their medical provider for instructions on how to proceed.

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: 198720024 and Lot numbers: 113812
  • 123509
  • 140578
  • 156210
  • 171659
  • 171660
  • 171661
  • 171662
  • 171663
  • 123509A
  • B34GE1000
  • B34GEA000
  • B4EGR1000
  • B4EGRA000
  • B4EGRB000
  • B4XFL1000
  • B4XFLA000
  • B5SH11000
  • B5SH1A000
  • B5SH1B

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 →

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