FDA-Device2014-12-24Class II
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
DePuy Orthopaedics, Inc.
Hazard
Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the
Sold states
Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
Affected count
19 units worldwide
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0825-2015Don't want to check this manually?
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