FDA Medical Device Recalls (openFDA)
J. Jamner Surgical Instruments, Inc.: 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.
- Recall number
- Z-0596-2007
- Recalling firm
- J. Jamner Surgical Instruments, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2006-11-14
- Posted
- 2007-03-08
- Terminated
- 2008-01-10
- 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.
- Root cause
- 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
- Domestic: 30 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Manufacturer lot numbers 55L and 125L
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDC
- Firm FEI
- 2430952
- Firm city
- Hawthorne
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28