PlainRecalls
FDA Devices Critical Class I Terminated

LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.

Reported: August 7, 2013 Initiated: July 11, 2013 #Z-1820-2013

Product Description

LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.

Reason for Recall

The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.

Details

Recalling Firm
DePuy Orthopaedics, Inc.
Units Affected
58 U.S. / 39 OUS
Distribution
Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NC, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 58 U.S. / 39 OUS.
Why was this product recalled?
The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 7, 2013. Severity: Critical. Recall number: Z-1820-2013.