Events

Rappel de Linear Straight Broach Handle, (Rasp Handle) EZ Clean" Linear Broach Handle

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 Greatbatch Medical.

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
    77120
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2055-2017
  • Date de mise en oeuvre de l'événement
    2017-04-23
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154992
  • 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
    Broach - Product Code HTQ
  • Cause
    Greatbatch medical has voluntarily initiated a recall for the linear straight broach handle (rasp handle) and ez clean" linear broach handle. greatbatch medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.
  • Action
    Greatbatch sent an Urgent Medical Device Recall letter dated April 23, 2017. The letter described the product being recalled and described Reason For Recall, Risk To Health, Replacement Devices, & Instructions to DJO Surgical Inc. Advised consignee to quarantine and return the affected product. If the product was further distributed they should contact the end users and share the recall information with them. Requested consignees to complete and return the "Field Recall Response Form" to Stericycle at Greatbatch4053@stericycle.com or fax it to 877-479-8063. For questions contact your Greatbatch Medical representative, or contact us at 1-763-951-8235, or e-mail us at fieldaction.center@integer.net. For further questions, please call (763) 951-8184.

Device

Linear Straight Broach Handle, (Rasp Handle) EZ Clean" Linear Broach Handle
  • Modèle / numéro de série
    Lot numbers : Linear Straight Broach Handle (Rasp Handle): 2988946, 3138186, 3185601, 3287315, 3300879, 3333172, 3433392, 3332697. EZ Clean" Linear Broach Handle: 3508491.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the state of : TX
  • Description du dispositif
    Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Adresse du fabricant
    Greatbatch Medical, 2300 Berkshire Ln N, Plymouth MN 55441-4575
  • Société-mère du fabricant (2017)
    Integer Holdings Corporation
  • Source
    USFDA