Omnilife Science Inc. recalls APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex In…
- Recall date
- June 4, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2445-2015
- FDA classification
- Class II
- Brand / firm
- Omnilife Science Inc.
- Sold / distributed
- US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
Why it was recalled
The device may have improper screw hole placement due to inaccurate location of the index line.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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