FDAMay 20, 2016device

K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, cou...

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

The hazard

The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.

What to do

FDA enforcement status: Terminated

Brands named

integra lifesciencesintegra

Recall history

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

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