Events

Recall of Device Recall Vanguard Universal Tibial Resection Block

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

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
    61274
  • Event Risk Class
    Class 2
  • Event Number
    Z-1223-2012
  • Event Initiated Date
    2012-02-14
  • Event Date Posted
    2012-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107700
  • 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
    This recall was initiated following a report that a bag labeled as ref. 32-487557/lot no 2561334 (vanguard tibial resection head universal w/ alignment tower) actually contained a ref. 32-487002/lot no. 2561329 (vanguard distal cutting block w/out handle attachment). investigation found packaging of the affected product may contain the incorrect item.
  • Action
    Biomet U.K. sent a Field Safety Corrective Action notice dated February 14, 2012 to all affected customers. The notice identified the affected products, problem and actions to be taken. Customers were instructed to locate, discontinue use and quarantine the recalled products pending return to Biomet. The letter recommended customers provide the notice to any other organization who may have received the affected instruments. Customers were instructed to complete and return without delay the attached "Fax-Back Response Form" acknowledging receipt of notice and indicating the quantity of products to be returned. For questions call +44 (0) 1656 761658, fax: +44 (0) 1656 645454 and e-mail uk.complaints@biomet.com

Device

Device Recall Vanguard Universal Tibial Resection Block
  • Model / Serial
    REF. 32-487557/ Lot no 2561334
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - in the countries of France, Japan, Italy, Netherlands, UK , no devices distributed in the USA
  • Product Description
    Vanguard Knee Instrumentation Tibial Resection Tower Universal with alignment tower geometry, REF 32487557, LOT 2561334, Biomet UK Ltd, South Wales, UK || Product Usage: Usage: Used to guide a saw blade in resecting the proximal tibia. Intended to be used with a tibial alignment guide.
  • Manufacturer
    Biomet U.K., Ltd.

Manufacturer

Biomet U.K., Ltd.
  • Manufacturer Address
    Biomet U.K., Ltd., Waterton Industrial Estate, Bridgend, South Wales United Kingdom
  • 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