Amendia, Inc: Medical Device Recall in 2017 - (Recall #: Z-1885-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 6, 2017

Date Posted: May 3, 2017

Recall Number: Z-1885-2017

Event ID: 77069

Reason for Recall:

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

Status: Terminated

Product Quantity: 15 units

Code Information:

Lot Number 135561

Distribution Pattern:

US distribution to GA, KS & TX

Voluntary or Mandated:

Voluntary: Firm initiated