FDADecember 16, 2019device

2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.

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

The hazard

There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.

What to do

FDA enforcement status: Terminated

Brands named

synthes

Recall history

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

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