medical MODERATE Updated 2022-04-27

Acumed LLC recalls 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 300

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Recalled Product

4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

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Hazard / Issue

Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Batch number distributed between 22 AUG 2018 to 07 FEB 2022 . UDI : 10806378022869

✅ 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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