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Signal Medical Corporation recalls Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x
Recalled October 29, 2014 · FDA recall Z-0109-2015 · Signal Medical
Hazard
Incorrect dimension on four liners was detected · FDA Class II
Units
12 devices
Sold at
US Distribution in MO only.
Description
Incorrect dimension on four liners was detected
Product
Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement.
Manufacturer(s)
Signal Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →