Events

Rappel de Device Recall TriMed SemiTubular Plate

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 Trimed 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
    75080
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2849-2016
  • Date de mise en oeuvre de l'événement
    2016-08-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149324
  • 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
    Trimed is recalling the semi-tubular plates with 10 holes (smtp-10) because a non-locking screw passed through a hole in a smtp-10 plate being implanted.
  • Action
    The firm, TriMed, sent a "Medical Device Recall Notification" Letter dated 8/29/16 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product subject to this recall; notify your customers at once of this product recall; discontinue use; return product, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form as soon as possible by Fax to: 1-661-254-8485 or email to: davidmedoff@trimedortho.com. Customers with questions are instructed to contact Director of Operations at (800) 633-7221, davidmedoff@trimedortho.com, M-F, 9am-5pm, Pacific Standard.

Device

Device Recall TriMed SemiTubular Plate
  • Modèle / numéro de série
    Lot no. 06206
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.
  • Description du dispositif
    TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 || Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.
  • Manufacturer
    Trimed Inc

Manufacturer

Trimed Inc
  • Adresse du fabricant
    Trimed Inc, 27533 Avenue Hopkins, Santa Clarita CA 91355-3910
  • Société-mère du fabricant (2017)
    Trimed Incorporated
  • Source
    USFDA