Events

Recall of Device Recall JariTrak Table Clamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by J. Jamner Surgical Instruments, 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
    37369
  • Event Risk Class
    Class 3
  • Event Number
    Z-0596-2007
  • Event Initiated Date
    2006-11-14
  • Event Date Posted
    2007-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50440
  • 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
    table clamp - Product Code KDC
  • Reason
    The jaritrak table clamp may not securely fasten to the bed rail of the or table during set up of the retractor system. in the event that the clamp is not securely fastened to the bed rail, the system may move during surgery. the firm received several complaints from hospitals.
  • Action
    On 11/14/06, an "URGENT-PRODUCT NOTIFICATION" letter (dated 11/14/06) and accompanying Fax Back Form were sent via Certified Mail Return Receipt Requested, to each customer that purchased or was supplied with the 206-160 Table Clamp. The letter instructs each surgical instrument coordinator (user) to review the inventory of 206-160 JariTrak" Table Clamps at the facility. The letter also provides instructions for the proper installation of the clamp to the bed rail. The customer is also asked to complete the Fax Back Form and fax it to back to Customer Service. J. Jamner Surgical Instruments, Inc. (J. Jamner) will replace any Table Clamps at the request of the customer. J. Jamner will account for all Fax Back replies and product returns. A second notification letter will be sent to any non-responding customers. Table Clamps returned from customers and from J. Jamner's inventory will be returned to the manufacturer, Koros USA Inc. or be destroyed by J. Jamner.

Device

Device Recall JariTrak Table Clamp
  • Model / Serial
    Manufacturer lot numbers 55L and 125L
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak™ Retractor System. The JariTrak™ self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or as part of the JariTrak™ retractor set.
  • Manufacturer
    J. Jamner Surgical Instruments, Inc.

Manufacturer

J. Jamner Surgical Instruments, Inc.
  • Manufacturer Address
    J. Jamner Surgical Instruments, Inc., 9 Skyline Dr, Hawthorne NY 10532-2100
  • Source
    USFDA