PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: February 27, 2013 Initiated: January 4, 2013 #Z-0828-2013

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
DePuy Orthopaedics, Inc.
Units Affected
162 total units (US) and 102 units total (OUS)
Distribution
Worldwide Distribution - US Nationwide in the states of 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 and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 162 total units (US) and 102 units total (OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 27, 2013. Severity: Critical. Recall number: Z-0828-2013.

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