Rappel de Device Recall T2 K Wire

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 Howmedica Osteonics Corp..

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Rod, fixation, intramedullary and accessories, metallic and non-collapsible - Product Code NDE
  • Cause
    A review of packaging revealed the seal integrity of the pouch may be compromised. more specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.
  • Action
    Stryker sent an Urgent Medical Device Removal letter dated November 9, 2016, to all affected customers via UPS (with return receipt). Stericycle will be handling the returns. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inform users of the Medical Device Recall and forward the notice to all those individuals who need to be aware within their organization. Return all affected products available at their location to: Stryker C/O Stericycle 2670 Executive Dr., Suite A Indianapolis, IN 46241 Attn: RA 2016-169 - Event XXX Customers were also instructed to complete and sign the enclosed Business Reply Form and return to Stericycle. Customers with questions should call +1-201-851-6683. For questions regarding this recall call 201-831-5000.


  • Modèle / numéro de série
    GAM Kirschner Wire - Manufacturing Part Number 12106450S, Lot #'s K0800BB, K0800BC, K0800BD, K0800BE, K0800BF, K0800C0, K081720, K081721, K0810872, K081723, K081727, K082C8B, K084F89, K084F98, K08683D, K08683E, K086841, K08820B, K089AF5, K08E1E1, K0911F4, K09379B, K096A26, K096A2A, K09A2C, K098213, K098215, K099AA0, K09AD33, K09BA4F, K09D564, K09F026, K0A1EF8, K0A1EFA, KoA1EFB, K0A38FB, K0A63AB, K0A63AC and K0A7BC1  T2 K-Wire - Manufacturing Part Number 18060050S, Lot #'s K084FBF, K0920A4, K0A1EFD, K093747, K0937C4, K09BA53, K09BA54, K09BA55 and K09BA56  T2 K-Wire Recon - Manufacturing Part Number 18063030S, Lot #'s K086847, K08E1E9 and K099AA8
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.
  • Description du dispositif
    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R || Intended for the temporary stabilization of bone segments or fragments
  • Manufacturer


  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Société-mère du fabricant (2017)
  • Source