Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

01.4mm x 457mm (18in) K-Wire Recalled by Amendia, Inc Due to Mislabeling

Date: April 6, 2017
Company: Amendia, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Amendia, Inc directly.

Affected 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

Quantity: 15 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 3 states: GA, KS, TX

Affected (3 states)Not affected

About Amendia, Inc

Amendia, Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report