Events

Recall of Guide Wires

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Amendia, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77069
  • Event Risk Class
    Class 2
  • Event Number
    Z-1885-2017
  • Event Initiated Date
    2017-04-06
  • Event Date Posted
    2017-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154922
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Mislabeled guide wires - it was discovered that some guide wires labeled as stainless steel were actually manufactured from nitinol.
  • 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.

Device

Guide Wires
  • Model / Serial
    Lot Number 135561
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US distribution to GA, KS & TX
  • 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
  • Manufacturer
    Amendia, Inc

Manufacturer

Amendia, Inc
  • Manufacturer Address
    Amendia, Inc, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • Manufacturer Parent Company (2017)
    Spinal Elements
  • Source
    USFDA