FDASeptember 16, 2019device

Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

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

The hazard

The subject product measures 4.0mm in diameter instead of 3.5mm.

What to do

FDA enforcement status: Terminated

Brands named

synthes usa productssynthessynthes usa

Recall history

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

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