medical MODERATE Updated 2020-08-05

Arthrex, Inc. recalls Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number

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Recalled Product

Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.

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Hazard / Issue

Screws provided in packaging are 5mm shorter than intended

Issued by

FDA

Distribution: International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
Lot/Code Info: Batch Number: 10706233 UDI Number:00888867056411

✅ 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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