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FDAJune 3, 2022device

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

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

The hazard

The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

What to do

FDA enforcement status: Completed

Brands named

safe orthopaedicssafe

UPCs

037602199100530376021991006003760219910091

Recall history

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

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