Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0831-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2013-01-04 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0831-2013
Date of alert
2013-01-04
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
DePuy Orthopaedics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
198720028
Reported risk: 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 sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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