Events

Recall of Synthes Matrix Mandible Short Cut Plate Cutter

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
    68111
  • Event Risk Class
    Class 2
  • Event Number
    Z-1781-2014
  • Event Initiated Date
    2014-04-22
  • Event Date Posted
    2014-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126954
  • 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
    Instrument, cutting orthopedic - Product Code HTZ
  • Reason
    It was discovered internally that the face of the synthes matrix mandible short cut plate cutter has the potential for discoloration/corroded material in the affected lot.
  • Action
    Synthes Inc. sent an Urgent Medical Device Recall Notice dated April 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you DO have any of the identified devices, please take the following steps: Contact DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) 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. Please include your name, title, 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. Return a copy of the Verification Section (page 3 of this letter) to DePuy Synthes by: Fax: 866-324-3731 or Scan/email: Synthes7726@stericycle.com 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 affecteded 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 Verification Section (page 3 of this letter) to DePuy Synthes by: Fax: 866-324-3731 or Scan/email: Synthes7726@stericycle.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

Synthes Matrix Mandible Short Cut Plate Cutter
  • Model / Serial
    part number: 03.503.057, lot number 8453237
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of CA, CT, FL, GA, NY, SD and TX.
  • Product Description
    Synthes Matrix Mandible Short Cut Plate Cutter || Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
  • 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