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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
Recalled May 3, 2017 · FDA recall Z-1885-2017 · Amendia
Hazard
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol. · FDA Class II
Units
15 units
Sold at
US distribution to GA, KS & TX
Description
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Product
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
Manufacturer(s)
Amendia, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →