Arthrex, Inc. recalls Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4
See all recalls from Arthrex, Inc. →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
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
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