FDA-Device2017-05-03Class II
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
Amendia, Inc
Hazard
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Sold states
US distribution to GA, KS & TX
Affected count
15 units
Manufactured in
1755 W Oak Pkwy, N/A, Marietta, GA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1885-2017Don't want to check this manually?
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