Events

Recall of Device Recall Malleable C Retractor

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
    70018
  • Event Risk Class
    Class 2
  • Event Number
    Z-0973-2015
  • Event Initiated Date
    2014-12-15
  • Event Date Posted
    2015-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132117
  • 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
    Retractor - Product Code GAD
  • Reason
    Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. surgical delay may occur. spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection.
  • Action
    The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated December 15, 2014, to its end users and sales consultants. The letter identified the product, problem, and actions to be taken. The End users/sales staff were instructed to immediately remove affected stock from inventory; call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number; complete and return the attached Verification Section to DePuy Synthes via fax: 866-827-3421 or Scan/email: Synthes8645@stericycly.com, even if you do not have any of the affected product, and return any affected devices to Synthes. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes sales consultant.

Device

Device Recall Malleable C Retractor
  • Model / Serial
    Part Number 397.232, Lot Numbers  1698700 4688882 4868698 5129449 5345722 6009689 6235842 6407718 1702300 4688883 4916060 5129450 5356127 6021041 6241331 6407719 1715800 4772507 4916061 5129453 5382066 6023019 6258401 6446480 175220 4772508 4916062 5247085 5422622 6023020 6258402 6446481 1685602 4814278 4991953 5247087 5664372 6040195 6300954 6452871 1695100 4814280 4991962 5263641 5664373 6040196 6321761 6452872 1695101 4814281 4992455 5267067 5685461 6056610 6345256 6623687 1706600 4868678 5032047 5267068 5820702 6097962 6345257 6633304 1776300 4868685 5080386 5287150 5839165 6181398 6355110  1798900 4868691 5080387 5287152 5855648 6212655 6407717
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and internationally to Canada.
  • Product Description
    Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.
  • 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