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FDANovember 8, 2016device

ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

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

The hazard

The firm discovered a lack of adequate documentation confirming sterility on certain products.

What to do

FDA enforcement status: Terminated

Brands named

wright medical technologywrightwright medical

Recall history

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

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ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538 — Recall Details · AllClear