Events

Recall of Device Recall LORENZ RESORBABLE DISTRACTOR SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Walter Lorenz Surgical, 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
    34843
  • Event Risk Class
    Class 2
  • Event Number
    Z-0384-2012
  • Event Initiated Date
    2006-02-17
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44813
  • 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
    Plate, bone - Product Code JEY
  • Reason
    Lorenz engineer discovered flex tube could break if bent too much.
  • Action
    W. Lorenz Surgical notified consignees of recall by an Urgent Advisory Notice letter. Consignees were requested to acknowledge receipt of recall and provide product disposition. Initial letter was sent on March 2, 2006, March 15, 2006, follow-up letters sent on April 4, 2006 and May 15, 2006. For additional information call (904) 741-4400 or fax (904) 741-4500.

Device

Device Recall LORENZ RESORBABLE DISTRACTOR SYSTEM
  • Model / Serial
    Lot # 976580 and Lot # 970060
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
  • Product Description
    Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." || W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DRIVE , REPLY TO POST OFFICE BOX 18009, JACKSONVILLE, FLORIDA 32229-8009 USA, 1-800-874-7711. || Part # 80-3112-01 Lot 976580 Qty 41 10/18/2005. || Sold for use with: || Part # 80-3112-01 Lot # 976580 Qty 28. || Part # SP-1652 Lot # 048720 Qty 3. || Part #-1640 Lot # 056620 Qty 8. || Part # SP-1651 Lot # 056590 Qty 2. || Part # 80-3112-01 Lot 970060 Qty 31 10/20/2005. || Sold for use with: || Part # SP-1651 Lot # 056590 Qty 8. || Part # SP-1653 Lot # 056610 Qty 10. || Part # SP-1285 Lot # 056570 Qty 4. || Part # SP-1652 Lot # 056600 Qty 9. || Product Usage: Distraction devices are for use in bone stabilization and elongation (lengthening) when correction of oral, cranial, mandibular and maxiollofacial deficiencies or post traumatic defects require gradual bone distraction. Each implantable distraction device has a titanium alloy drive screw mechanism and LactoSorb resorbable correction plates, which are implanted by fixation with LactoSorb bone screws.
  • Manufacturer
    Walter Lorenz Surgical, Inc.

Manufacturer

Walter Lorenz Surgical, Inc.
  • Manufacturer Address
    Walter Lorenz Surgical, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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