medical MODERATE Updated 2020-03-25

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

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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.

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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?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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