Agency classClass IOur severity:Severe FDA (Devices)·Z-0828-2013·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 as a Class I recall, and the rubric mandates a score of at least 4 for FDA Class I recalls. Additionally, the potential for fracture in a load-bearing joint implant represents a significant injury risk.

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 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 states such as AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV, as well as in Holland, Australia, Austria, South Africa, and Canada, including Veteran Administration hospitals. Affected part number is 198720018, with specific lot numbers listed in the agency documentation.

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-failure

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 (15)

Part number: 198720018 and Lot numbers: 123506
123507
156208
188414
202951
212351
B34GC1000
B4EGN1000
B4SBM1000
B5SHY1000
DH8F91000
DH8F9A000
DH8F9B000
DH8F9C
and FE5LL1.

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