FDA-Device2020-03-25Class II
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.
Arthrex, Inc.
Hazard
Screws provided in the device package are 6 mm longer than intended.
Sold states
US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
Affected count
20 units
Manufactured in
1370 Creekside Blvd, Naples, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2020Don't want to check this manually?
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