Events

Rappel de Device Recall MANOS EX

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 Thayer Intellectual Property, 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
    75630
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0702-2017
  • Date de mise en oeuvre de l'événement
    2016-11-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150962
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    The firm failed to notify current customers of ifu update/warning. during a recent fda inspection, it was discovered that thayer intellectual property, inc. had revised their ifu to include a warning not to bend, deform or otherwise modify any part of the device. the warning was added as a result of a maude report filed in december 2014 where a piece of the manos ex broke during use and was left in the patient's hand. the patient suffered a tendon injury and an additional surgery was required to remove the broken piece of the device and repair the tendon. fda inspection found that while the firm had updated their ifu, they had not notified customers who had been shipped the device with the older version that did not include the warning. risk: it is important for manos ex users to be aware that bending, deforming, or modifying the device could result in device breakage which could impact patient safety and device performance.
  • Action
    Thayer sent an Urgent Medical Device Correction letters dated November 4, 2016 by Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were asked to check if any of the affected lots were still available, and if so, to change out the IFU with version 5. For questions call 415-923-9375.

Device

Device Recall MANOS EX
  • Modèle / numéro de série
    LOT 1055337, Expiry 4/01/2015; LOT 1071800. Expiry 5/1/2017; LOT 1102580; Expiry 8/1/2017; LOT 1154179; Expiry 12/01/2017.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of CA, TX. MD, MI,VA, DC, UT, CT, ID, SD, IN, and GA.
  • Description du dispositif
    MANOS EX (CAT#TY-12-101) || Product Usage: || Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.
  • Manufacturer
    Thayer Intellectual Property, Inc.

Manufacturer

Thayer Intellectual Property, Inc.
  • Adresse du fabricant
    Thayer Intellectual Property, Inc., 1331 N California Blvd Ste 320, Walnut Creek CA 94596-4563
  • Société-mère du fabricant (2017)
    Thayer Intellectual Property Inc.
  • Source
    USFDA