Events

Rappel de Device Recall Timberline Retractor Blade

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 Biomet Spine, 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
    70381
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1069-2015
  • Date de mise en oeuvre de l'événement
    2012-02-22
  • Date de publication de l'événement
    2015-02-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133381
  • 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
    Biomet spine, llc is recalling the timberline cranial caudal and posterior blades, 40-180mm due to oversize of the set screw hex feature.
  • Action
    Biomet initiated the recall on February 22, 2012, No letters were or will be sent to customers. 100% retrieval was achieved by working directly with the customers. For questions regarding this recall call 303-501-8548.

Device

Device Recall Timberline Retractor Blade
  • Modèle / numéro de série
    Model #8734-2XXX, 8734-5XXX. Lot #L556219. Product Code: 8734-2060, CC Blade, 60mm 8734-2070, CC Blade, 70mm 8734-2080, CC Blade, 80mm 8734-2090, CC Blade, 90mm 8734-2100, CC Blade, 100mm 8734-2110, CC Blade, 110mm 8734-2120, CC Blade, 120mm 8734-2130, CC Blade, 130mm 8734-2140, CC Blade, 140mm 8734-2150, CC Blade, 150mm 8734-2160, CC Blade, 160mm 8734-2170, CC Blade, 170mm 8734-2180, CC Blade, 180mm 8734-5050, Posterior Blade, 50mm 8734-5060, Posterior Blade, 60mm 8734-5070, Posterior Blade, 70mm 8734-5080, Posterior Blade, 80mm 8734-5090, Posterior Blade, 90mm 8734-5100, Posterior Blade, 100mm 8734-5110, Posterior Blade, 110mm 8734-5120, Posterior Blade, 120mm 8734-5130, Posterior Blade, 130mm 8734-5140, Posterior Blade, 140mm 8734-5150, Posterior Blade, 150mm 8734-5160, Posterior Blade, 160mm 8734-5170, Posterior Blade, 170mm 8734-5180, Posterior Blade, 180mm
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA.
  • Description du dispositif
    Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure || Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
  • Manufacturer
    Biomet Spine, LLC

Manufacturer

Biomet Spine, LLC
  • Adresse du fabricant
    Biomet Spine, LLC, 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • 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