Events

Rappel de Device Recall OPT Croutons synthetic bone substitute

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 Acumed 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
    75904
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1019-2017
  • Date de mise en oeuvre de l'événement
    2016-12-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151650
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Cause
    Opt croutons, part number 65-0210-s, is recalled due to the result of inadequate documentation of the sterilization dose used in production. product sterilized at the site did not receive the minimum dose required per the new performance qualification.
  • Action
    Acumed sent the Urgent Recall Notice letter, dated December 1, 2016, to US customers on December 5, 2016. Customers are advised to follow the instructions provided by Acumed: IMMEDIATELY stop using and/or distributing the product and complete the following actions: 1. Perform a physical count of your inventory. 2. Remove the affected OPT Croutons, such that the croutons are out of service. 3. Record this data on the survey found following this recall letter. 4. Fill out the survey and return it via email to RecaiiNotification@acumed.net. 5. For any product that needs to be returned: Domestic Customers: please contact Acumed Agent Inventory via email at Agentlnventory@acumed.net or contact your agent directly to be assigned a Return Material Authorization (RMA) number and applicable shipping information. International Customers: please contact Acumed Business Services via email at BusinessServices@acumed.net or via phone at (877) 627-9957 Option 4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US and Canada) to be assigned a Return Material Authorization (RMA) number and applicable shipping information. 6. Once completed, please return the OPT Croutons that have been removed to Acumed using the Return Label provided by Acumed and included in your replacement shipment. Please contact Acumed Business Services via email at BusinessServices@acumed.net or via phone at (877) 627-9957 Option 4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US and Canada) with any questions regarding this notification.

Device

Device Recall OPT Croutons synthetic bone substitute
  • Modèle / numéro de série
    lot 549/12.001. Part number 65-0210-S.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
  • Description du dispositif
    OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
  • Manufacturer
    Acumed LLC

Manufacturer

Acumed LLC
  • Adresse du fabricant
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Société-mère du fabricant (2017)
    Acumed Llc
  • Source
    USFDA