Z-1885-2017Class II

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

Name: Z-1885-2017 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper...
Creator: Amendia, Inc
Published: 2017-04-06
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2017-04-06 / Terminated / root cause: manufacturing process

FDA source

Amendia, Inc began a recall of 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... on 2017-04-06. FDA classified it as Class II and gives the reason as "Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1885-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-06
Posted: 2017-04-25
Terminated: 2017-05-30
Recalling firm: Spinal Elements, Inc
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
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 15 units
Distribution: US distribution to GA, KS & TX
Product codes and lots: Lot Number 135561

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1885-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1885-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-03	2017-04-27

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)