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.

Reason: Screws provided in the device package are 6 mm longer than intended.

Code information: Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424

Distribution pattern: US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China