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FDAMarch 9, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Completed

Brands named

acumed

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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