Events

Rappel de 2.7 MM Locking Screw SLFTPNG with T8 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
    72345
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0167-2016
  • Date de mise en oeuvre de l'événement
    2015-10-06
  • Date de publication de l'événement
    2015-10-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140704
  • 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
    Specific lots of the ss 2.7mm locking screw have been mislabeled as ss 2.4mm locking screw.
  • Action
    Synthes sent an URGENT NOTICE: MEDICAL DEVICE NOTIFICATION UPDATED INFORMATION: CORRECTED LOT NUMBER SS 2.7mm Locking Screw, self-tapping letter dated January 13, 2014, to the affected customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. Return the Verification Form (page 3 of this letter) with the product to: Credit/Returns, Synthes. If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. Return the documents to Synthes by: Fax: 1-866-792-5446 or Scan/email: FieldAction@synthes.com If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. For further questions please call 610-719-6500.

Device

2.7 MM Locking Screw SLFTPNG with T8 Stardrive Recess 12MM
  • Modèle / numéro de série
    Part Number 202.212 Lot Number 3420620
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the state of : TN
  • Description du dispositif
    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
  • 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