Events

Rappel de Device Recall Low Profile U Joint Driver for the SynFix Mini Open 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 Synthes Spine.

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
    50523
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0931-2009
  • Date de mise en oeuvre de l'événement
    2008-11-20
  • Date de publication de l'événement
    2009-01-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-10-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75693
  • 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
    Lumbar Intervertebral Fusion Device with Bone Graft - Product Code MAX
  • Cause
    Screwdriver tip may break off and lodge in the screw head.
  • Action
    The recalling firm emailed all Spine Sales Consultants on 11/20/08. They were instructed to immediately examine their stock and discuss appropriate technique with surgeon users. In addition, a Medical Device Correction letter dated 11/19/08 was issued via USPS certified mail to the medical facilities. This initial letter stated the issue and requested the users take the following actions: discard all SynFix Technique Guides and replace with the updated literature contained in the mailing packet with the letter, and is identified by code J7022-E (Rev. E); to ensure receipt and understanding of the information, the Verification Section of the letter needs to be completed and returned to Synthes by either fax: 610-719-5120 or scan/e-mail: lewis.lynne@synthes.com. An Urgent: Medical Device Recall letter, dated 1/16/2009, was also sent out. This latter letter requested that users examine their stock immediately and remove any of the affected devices from their inventory. Customers are also to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the Verification Section; and return the letter with the recalled product to the address listed. There are also actions for those who do not have the affected product. Questions should be directed to 800-620-7025 x 5453 or 610-719-5453.

Device

Device Recall Low Profile U Joint Driver for the SynFix Mini Open System
  • Modèle / numéro de série
    Lot numbers: 2317363, 2331806, 2331810, 2387975, 2387976, 2401982, 5637286, 5644605, 5660377, 5664629, 5826243, and 5826244.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Class II Recall - Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA ,SC, TN, TX, UT, VA, WA, and WI, and countries of Canada and Switzerland.
  • Description du dispositif
    Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. || The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autograft.
  • Manufacturer
    Synthes Spine

Manufacturer

Synthes Spine
  • Adresse du fabricant
    Synthes Spine, 1302 Wrights Ln E, West Chester PA 19380-3417
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA