Events

Recall of Device Recall Construx Alum Ankle Clamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet, 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
    71255
  • Event Risk Class
    Class 2
  • Event Number
    Z-1741-2015
  • Event Initiated Date
    2015-05-01
  • Event Date Posted
    2015-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137058
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Reason
    Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. this prevents complete range of motion and if pushed too far may loosen the pin from the bone. a revision surgery may be necessary to adequately reconnect the fixator to the bone.
  • Action
    Biomet sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated May 1, 2015 to the affected distributors and implanting surgeons. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and distributor instructions for responding to the formal recall notification. Consignees were instructed to return the affected product and continued monitoring of patients. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Device Recall Construx Alum Ankle Clamp
  • Model / Serial
    Part 14-450510 Lots:268000, 466170, and 813950
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
  • Product Description
    Unilateral external fixation ankle clamp || Product Usage: || Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA