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Arthrex, Inc. recalls Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line o
Recalled March 25, 2020 · FDA recall Z-1510-2020 · Arthrex
Hazard
Screws provided in the device package are 6 mm longer than intended. · FDA Class II
Units
20 units
Sold at
US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
Description
Screws provided in the device package are 6 mm longer than intended.
Product
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
Manufacturer(s)
Arthrex, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →