Events

Rappel de Device Recall Synthes Interlocking Bolt, 151mm

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 Synthes (USA) Products LLC.

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
    73600
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1312-2016
  • Date de mise en oeuvre de l'événement
    2016-02-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144554
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Cause
    Depuy synthes is initiating a voluntary medical device recall of certain lots of the interlocking bolt which are a part of the synthes 4.5 mm lcp proximal tibia plate system. the synthes 4.5 mm lcp proximal tibia plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combi.
  • Action
    DePuy Synthes sent an Urgent Notice to inform customers that they were initiating a voluntary recall of lot numbers: 1776197, 5706588, 1782340 and 1868678 of the Interlocking Bolt which are part of the Synthes 4.5mm LCP Proximal Tibia Plate System. Customers were asked to review their inventory for the affected lots, call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verifcation Section (page 3 of the letter) identifying that the affected product has been located and return it to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. A copy of the Verification Section of the letter was to be faxed to 866-737-4701 or emailed to: Synthes2856@stericycle.com.

Device

Device Recall Synthes Interlocking Bolt, 151mm
  • Modèle / numéro de série
    Lot Number# 1776197 (5706588), 1782340 and 1868678 Catalog ID 03.120.027 For lot 1776197, the part is etched with 1776197; the package label documents 5706588.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
  • Description du dispositif
    Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Adresse du fabricant
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA