JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak Table Clamp with vertical pos

FDA device recall Z-0596-2007 · posted 2007-03-08 · Terminated

Recall details

Recalling firm

J. Jamner Surgical Instruments, Inc.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

KDC

Quantity affected

Domestic: 30 units

Distribution

Nationwide

Date initiated

2006-11-14

Date posted

2007-03-08

Date terminated

2008-01-10

Location

Hawthorne, NY