Events

Rappel de Ulnar Shortening Saw 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 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
    55410
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1807-2010
  • Date de mise en oeuvre de l'événement
    2010-04-14
  • Date de publication de l'événement
    2010-06-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-06-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90774
  • 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
    plate, fixation, bone - Product Code HRS
  • Cause
    The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union.
  • Action
    On April 14, 2010, Acumed began contacting consignees by telephone. On April 15, 2010, Acumed sent out the URGENT NOTICE: DEVICE RECALL Initial Notification letter and Recalled Product Status Form to their consignees. The letter describes the recall product as Ulnar Shorting Saw Blade-Hub Style S, Part no. 80-0499-S and Lot Codes. The Initial Notification letter instructs consignees to return the product back to Acumed immediately and notify their sub-accounts (customers) if products have been further distributed. The consignees also are asked to fill out and send back the Recalled Product Status Form . Customers should call the Customer Service at 1-888-627-9957 or e-mail to RecallNotification@acumed.net for any questions regarding the recall.

Device

Ulnar Shortening Saw Blade
  • Modèle / numéro de série
    Part Number: 80-0499-S Lot Numbers: 214436, 215637, 215638, 215639, 215640, 215641, 219931, and 220909.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA and to the following countries: Spain, Great Britain, South Africa, Puerto Rico, Canada, Turkey, Ireland, Finland, Belgium, Australia, Germany, and Sweden.
  • Description du dispositif
    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". || The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. || The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. || Intended use: Cutting Bones
  • 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