Events

Recall of Device Recall ROIA Anterior Delivery Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LDR Spine USA, 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
    75068
  • Event Risk Class
    Class 2
  • Event Number
    Z-0045-2017
  • Event Initiated Date
    2016-08-29
  • Event Date Posted
    2016-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149274
  • 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
    The roi-a anterior delivery device t-handle, part number si-roia-0023 has experienced binding of the rotation of the t-handle. there have been no reports of patient injury.
  • Action
    The firm, LDR, contacted affected consignees via phone and then sent a follow up email dated 9/8/16. The phone script and email described the product, problem and actions to be taken. The consignees were instructed to promptly return the instrument using the RMA#1180. The firm will perform a rework that prevents the binding to occur. If you have any question, contact the Quality Engineering Manager by email: ron.musselman@zimmerbiomet.com, phone: 512-344-3436 or Field Inventory Manager - US Supply Chain or phone: 512-344-3436.

Device

Device Recall ROIA Anterior Delivery Device
  • Model / Serial
    Lot # 2295101A, 2295101A-R, 2296101A-R
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
  • Product Description
    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 || Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
  • Manufacturer
    LDR Spine USA, Inc.

Manufacturer

LDR Spine USA, Inc.
  • Manufacturer Address
    LDR Spine USA, Inc., 13785 Research Blvd Ste 200, Austin TX 78750-1895
  • 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