Events

Rappel de Device Recall Synthes 2.4mm Titanium Locking Screws SelfTapping with Stardrive Recess 12mm

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
    74719
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2389-2016
  • Date de mise en oeuvre de l'événement
    2016-06-28
  • Date de publication de l'événement
    2016-08-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148285
  • 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
    Plate, fixation, bone - Product Code HRS
  • Cause
    It was reported that the specified lots of the 2.4mm titanium locking screw self-tapping with stardrive recess 12mm can break between the head and the shaft. this resulted from the neck feature being too close to the stardrive feature leaving a thin wall between neck and drive.
  • Action
    The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated July 14, 2016 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove and return all unpackaged Locking Screws Self-Tapping with Stardrive Recess 12mm in any affected kits along with any screws still in the original packaging with the part number and lot number identified in the recall notification. Customers were also instructed to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section and indicate the number of devices found and return with product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 by fax to 877-523-9109 or scan/email: Synthes5246@stericycle.com, even if you do not have the product. Note: if the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Device

Device Recall Synthes 2.4mm Titanium Locking Screws SelfTapping with Stardrive Recess 12mm
  • Modèle / numéro de série
    Lot Number: 9942217 Part Number: 412.812
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to states of: AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MN, NJ, OK, PA, SD, TN, and WA.
  • Description du dispositif
    Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices || The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following systems: - 2.4. mm Titanium LCP Distal Radius Plate System - Titanium LCP Compact Distal Radius System - 2.4 mm Titanium LCP Radial Head Plate Set - Titanium Modular Mini Fragment LCP System - 2.4 mm Titanium Variable Angle LCP Distal Radius System - 2.7 mm/3.5 mm Titanium Distal Fibula Plate System
  • 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