Events

Rappel de Device Recall Pathfinder NXT Closure Top Driver Long

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 Zimmer 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
    58536
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2722-2011
  • Date de mise en oeuvre de l'événement
    2011-05-20
  • Date de publication de l'événement
    2011-07-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99671
  • 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
    Screwdriver - Product Code HXX
  • Cause
    Zimmer spine, inc. is initiating a voluntary recall regarding an increased risk of rounding or partial rounding of the hex tip on the 3566-1 (long) and 3566-2 (short) closure top driver used for insertion, provisional tightening, and final locking of closure tops during the screw and rod construct assembly of the pathfinder nxt pedicle screw system. when the hex tip of the closure top driver is.
  • Action
    Zimmer, Inc. issued an "URGENT MEDICAL DEVICE RECALL" letters dated April 2011, to all affected customers. The letter identified the product, problem and actions to be taken. The customers were instructed that (THE GOLD CLOSURE TOP DRIVERS 3566-1 and 3566-2 ARE NOT TO BE USED FOR FINAL TIGHTENING); an alternate instrument for final construct tightening will be included in the instrument set 3570-1 short and 3570-2 long (These instruments are silver instead of gold for easy identification and do not include a retention feature for holding the Closure Top); to ensure final drivers are added to each PathFinder NXT set and inspect Closure Top Drivers for rounded hex wear; contact their customer service representative if they do not have both versions; and complete and return all attached forms via fax to: Zimmer Spine at 512-258-0995. The letter states that the firm will revise the surgical technique to show the updated uses of the screwdrivers. Please keep Zimmer Spine informed of any adverse events associated with the device or any other Zimmer spine product by calling 800-326-0635. For any further questions or concerns contact the Vice President Quality Assurance & Regulatory Affairs at 800-655-2614.

Device

Device Recall Pathfinder NXT Closure Top Driver Long
  • Modèle / numéro de série
    REF 3566-1 Lots 62TP, 63SG, 65DE, 66CH.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including states of: AZ, CA, WI, MI, KS, OK, TX, GA, TN, FL, NJ, CT, PA and the countries of: Australia and Italy.
  • Description du dispositif
    Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN || Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Adresse du fabricant
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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