Events

Rappel de Device Recall Instratek Carpal Tunnel Release Blades

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 Surgical Instrument Service And Savings, 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
    65205
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1623-2013
  • Date de mise en oeuvre de l'événement
    2013-05-03
  • Date de publication de l'événement
    2013-07-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118229
  • 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
    Knife, surgical - Product Code EMF
  • Cause
    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
  • Action
    MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.

Device

Device Recall Instratek Carpal Tunnel Release Blades
  • Modèle / numéro de série
    122279; 122493; 122504; 122609; 122669; 123190
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 || -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 || -Linvatec CTS Relief Kit. REF 9971, lot 122504 || -Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060. Lot 122504 and Lot 123190. || -KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White). REF 08-0003. Lot # 122609 || Surgical Knife
  • Manufacturer
    Surgical Instrument Service And Savings, Inc.

Manufacturer

Surgical Instrument Service And Savings, Inc.
  • Adresse du fabricant
    Surgical Instrument Service And Savings, Inc., 2747 Sw 6th St, Redmond OR 97756-7109
  • Société-mère du fabricant (2017)
    Medline Industries Inc.
  • Source
    USFDA