Events

Recall of Device Recall Timberline Anchored Lateral Variable Retractable Sleeve

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

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
    70060
  • Event Risk Class
    Class 2
  • Event Number
    Z-0978-2015
  • Event Initiated Date
    2013-08-22
  • Event Date Posted
    2015-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132196
  • 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
    Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
  • Reason
    The inner diameter of the sleeve shaft is undersized, resulting in interference fit when inserting the anchored lateral straight retractable awl or the anchored lateral straight retractable drill into the sleeve shaft.
  • Action
    The firm, Lanx, sent their Consignees/customers a letter dated October 15, 2013. The letter described the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with the conforming product. Please contact the Chief Compliance Officer at 303-501-8534 or by email: Randy.fesmire@lanx.com.

Device

Device Recall Timberline Anchored Lateral Variable Retractable Sleeve
  • Model / Serial
    Model 8630-0204 Lots TU00052, TU00052A, and TU00117
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
  • Product Description
    Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 || Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
  • Manufacturer
    Biomet Spine, LLC

Manufacturer

Biomet Spine, LLC
  • Manufacturer Address
    Biomet Spine, LLC, 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • 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