FDANovember 17, 2017device

STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.

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

The hazard

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

What to do

FDA enforcement status: Terminated

Brands named

stryker

UPCs

04546540754561

Recall history

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

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