Events

Rappel de Device Recall LORENZ RESORBABLE DISTRACTOR SYSTEM

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Walter Lorenz Surgical, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    34843
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0385-2012
  • Date de mise en oeuvre de l'événement
    2006-02-17
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44814
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Plate, bone - Product Code JEY
  • Cause
    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
  • Modèle / numéro de série
    Lot # 968720
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
  • Description du dispositif
    Product is 35mm Flex 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 # SP-1328-01 Lot 968720 Qty 34 10/6/2005. || Sold for use with: || Part # SP-1598-13 Lot # 041950 Qty 10. || Part # SP-1597-13 Lot # 066720 Qty 9. || Part # SP-1598-13 Lot 050140 Qty 15. || 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.
  • Adresse du fabricant
    Walter Lorenz Surgical, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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