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

FDA device recall Z-1885-2017 · posted 2017-04-25 · Terminated

Recall details

Recalling firm

Amendia, Inc

Reason for recall

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

Action taken

Amendia sent an Urgent Medical Device Recall Letter dated April 6, 2017, and April 25, 2017, to all affected customers. The letter requested that they check inventory, quarantine product for return to Amendia, and requested a sub-recall. The letter also included a reply form to be returned to Amendia. Customers with questions were instructed to call Amendia Customer Service at 770-575-5224. For questions regarding this recall call 404-610-7215.

Root cause

Process design

Status

Terminated

Product code

LXH

Quantity affected

15 units

Distribution

US distribution to GA, KS & TX

Date initiated

2017-04-06

Date posted

2017-04-25

Date terminated

2017-05-30

Location

Marietta, GA