Amendia product recalled over labeling errors

Recall date

April 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Amendia, Inc recalls 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM…

Recall number

Z-1885-2017

FDA classification

Class II

Brand / firm

Amendia, Inc

Sold / distributed

US distribution to GA, KS & TX

Why it was recalled

Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery