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FDAMarch 30, 2017device

RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)

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

The hazard

The stability data does not support the product labeled with a 10-year shelf life.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

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

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