Events

Rappel de Device Recall Altius MINI OCT Posterior Spinal Fixation 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 Zimmer Biomet Spine, 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
    76610
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1691-2017
  • Date de mise en oeuvre de l'événement
    2017-03-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153660
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Cause
    Zimmer biomet is recalling the altius m-ini oct posterior spinal fixation system because the driver is unable to mate with the screw head tulip.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall letter on March 20, 2017, to all affected consignees. The letter identified the product, the problem and the action to be taken by the consignee. Consignee's Responsibilities 1. Review this notification and ensure affected team members are aware of the contents. 2. Prior to sending Altius Kits to central processing, perform a functional check of the driver withall screws in the kit to ensure they mate. If the drivers do not mate, please return in accordance with Step 3b. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form  Phase I. b. If the driver is unable to mate with the screws in the set, immediately sterilize and return the affected nonconforming product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form  Phase I and Attachment 2  Certificate of Sterilization to Zimmer Biomet. i. For each return, send a copy of Attachment 1 to jeremy.hansmann@zimmerbiomet.com ii. Include a hardcopy of Attachment 1 with your shipment for immediate processing. iii. Include a copy of Attachment 2  Certificate of Sterilization with returned instruments. iv. Mark the outside of the returns box(es) clearly with RECALL. 4. Distributors will notify their accounts to which the product was further distributed and to locate and return products from these accounts. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that have the affected product. If there are no additional users to notify, please confirm this by annotating and returning the form provided indicating that no additional users have been identified. 5. Retain a copy of your field action acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 6. If

Device

Device Recall Altius MINI OCT Posterior Spinal Fixation System
  • Modèle / numéro de série
    505951,M16562R01,505951,510710,510981,514814,533566,536398,543663,546565,546566,549528,565465,565464,567525,
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to the Netherlands
  • Description du dispositif
    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 || The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only
  • Manufacturer
    Zimmer Biomet Spine, Inc

Manufacturer

Zimmer Biomet Spine, Inc
  • Adresse du fabricant
    Zimmer Biomet Spine, Inc, 310 Interlocken Pkwy, Suite 120, Broomfield CO 80021-3479
  • 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