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U.S. Department of Health and Human Services

Class 3 Device Recall JariTrak Table Clamp

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  Class 3 Device Recall JariTrak Table Clamp see related information
Date Initiated by Firm November 14, 2006
Date Posted March 08, 2007
Recall Status1 Terminated 3 on January 10, 2008
Recall Number Z-0596-2007
Recall Event ID 37369
Product Classification table clamp - Product Code KDC
Product 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.
Code Information Manufacturer lot numbers 55L and 125L
Recalling Firm/
Manufacturer		 J. Jamner Surgical Instruments, Inc.
9 Skyline Dr
Hawthorne NY 10532-2100
For Additional Information Contact Mr. Eric R. Gillman
609-936-2378
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce Domestic: 30 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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