Events

Recall of DePuy Synthes TI Vectra Plates

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69178
  • Event Risk Class
    Class 2
  • Event Number
    Z-2674-2014
  • Event Initiated Date
    2014-09-02
  • Event Date Posted
    2014-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129804
  • Notes / Alerts
    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.
  • Extra notes in the data
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Reason
    Depuy synthes is initiating a voluntary medical device recall of certain lots of the ti vectra plates, which is a part of the depuy synthes vectra anterior cervical plate family of systems. the vectra systems are intended for anterior screw fixation to the cervical spine (c2-c7). it was discovered in certain lots, that the clips are potentially missing from the ti vectra plates resulting in the i.
  • Action
    DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated September 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 3 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, address, telephone number and signature in the spaces provided. Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: Fieldaction@synthes.com If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical information. Return the documents to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: Fieldaction@sythes.com 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 on page 3 of the notification. If you have any questions, please call 610-719-5450, or contact your DePuy Synthes sales consultant.

Device

DePuy Synthes TI Vectra Plates
  • Model / Serial
    TI Vectra-One" Plate 2 Level / 34 mm  part 04.613.184  3337672  TI Vectra" Plate 3 Level / 57 mm  part 04.613.257  lot 3693878  TI Vectra" Plate 4 Level / 64 mm  part 04.613.364  lot 8143905
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution including the states of IL, SC, VA, TX, MA, NC, LA, CA, AL, CO, NE, OR and KS., and Internationally to Canada.
  • Product Description
    DePuy Synthes TI Vectra Plates: || TI Vectra-One" Plate 2 Level / 34 mm || part 04.613.184 || 3337672 || TI Vectra" Plate 3 Level / 57 mm || part 04.613.257 || lot 3693878 || TI Vectra" Plate 4 Level / 64 mm || part 04.613.364 || lot 8143905
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Manufacturer Address
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA