FDAApril 25, 2024device

STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010

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

The hazard

Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay

What to do

FDA enforcement status: Ongoing

Brands named

synthes usa productssynthessynthes usa

UPCs

10886982075192

Recall history

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

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