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Omnilife Science Inc. recalls APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Ap
Recalled September 2, 2015 · FDA recall Z-2445-2015 · Omnilife Science
Hazard
The device may have improper screw hole placement due to inaccurate location of the index line. · FDA Class II
Units
112
Sold at
US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
Description
The device may have improper screw hole placement due to inaccurate location of the index line.
Product
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
Manufacturer(s)
Omnilife Science Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →