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Terminated

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

FDA Recall Z-1885-2017 · Posted 2017-04-25

Recalling FirmAmendia, Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-04-06
Date Terminated2017-05-30
Product Quantity15 units

Reason for Recall

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

Firm Action

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

Distribution Pattern

US distribution to GA, KS & TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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