Events

Rappel de Device Recall Universal Spinal System Lamina Hooks

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 (USA) Products LLC.

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
    62324
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2054-2012
  • Date de mise en oeuvre de l'événement
    2012-05-31
  • Date de publication de l'événement
    2012-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110226
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Cause
    Uss lamina hooks, medium, right are being recalled because the hooks are etched with the wrong part number - 498.321 (lamina hook, medium, left). the lamina hooks should be etched with part number 498.320 (lamina hook, medium, right).
  • Action
    SYNTHES sent a Medical Device Recall letter dated May 31, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees and sales reps remove recalled product from their inventory, call the firm at 1-800-479-6329 to receive an authorization number and complete the enclosed verification form and return to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, Colorado 80132. If customers do not have any of the affected product they were instructed to complete the Verification Section at the end of the letter by checking the appropirate box indicating that no affected porudct has been located. Return the document to Synthes by fax to 610-251-9005 or Scan/Email: FieldAction@synthes.com. For any questions please call 610-719-5450.

Device

Device Recall Universal Spinal System Lamina Hooks
  • Modèle / numéro de série
    Catalog number 498.321, lot/serial #6876785
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including GA, PA, SC, TX, and UT and Canada.
  • Description du dispositif
    Universal Spinal System Lamina Hooks || Synthes Medium TI Lamina Hook - Right || 498.320 || Non sterile || LOT 6876785 || Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Adresse du fabricant
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA