Events

Rappel de Device Recall Mantis Tap Sleeve

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 Stryker Spine.

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
    57665
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1247-2011
  • Date de mise en oeuvre de l'événement
    2011-01-07
  • Date de publication de l'événement
    2011-02-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96941
  • 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
    Stryker spine has received reports that after sterilization but prior to surgery, cracks were noticed at the tantalum marker / pei tube interface. this can likely be attributed to differences in the rate of thermal expansion between the markers and the sleeve during the sterilization cycle.
  • Action
    Stryker Spine sent an Urgent Product Recall letter dated January 07, 2011, to Stryker Spine sales branches and agencies where affected product was distributed. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and hospital locations to identify the product. Reconcile any Mantis Tap Sleeves with the catalog and lot numbers referenced in the letter. Complete the Customer Response Form with distribution sheet provided to assist with product reconcilation. Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370. Customers were to retrieve and return the affected product using the enclosed pre-paid mailing label to Regulatory Compliance, Stryker Spine 6 Pearl Court, Allendale, New Jersey 07401. For questions call 201-760-8180.

Device

Device Recall Mantis Tap Sleeve
  • Modèle / numéro de série
    All lots - Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalog #IS830MAN; Custom Tap Sleeve, Mantis - Catalog #IS2271MAN; and Custom Mantis Modular Tap Set - Catalog #IS2080MAN. All lots
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including MA, MN, and PA.
  • Description du dispositif
    Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following products: || Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalog #IS830MAN; Custom Tap Sleeve, Mantis - Catalog #IS2271MAN; and Custom Mantis Modular Tap Set - Catalog #IS2080MAN || The Mantis Tap Sleeves with Markers was designed to be used in a manner identical to the predicate Standard Mantis Tap Sleeve 48281315. It is to be used in conjunction with Standard Mantis Cannulated Modular Taps: 1) to protect soft tissue from the cutting edge of the tap 2) to indicate the depth at which the Tap has been inserted.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Adresse du fabricant
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA