medical Class II Updated 2020-03-25

Arthrex, Inc. recalls Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Affected States: MA, MN, ND, OH, SD, TN
Lot/Code Info: Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424
View official government recall

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