FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
- Recall number
- Z-0001-2007
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
- Status
- Terminated
- Initiated
- 2006-05-31
- Posted
- 2006-10-03
- Terminated
- 2011-07-27
- Reason
- Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.
- Root cause
- Process control
- Action
- Consignees were notified by letter on 05/31/2006
- Quantity
- 143 units
- Distribution
- Nationwide, including one VA facility in PA. No military distribution. Foreign distribution to Canada, China, Italy, Japan, Spain.
- Lot, serial or model codes
- ALL LOT NUMBERS -GE Part number 1006385 or 1006385-NAV
- 510(k) numbers
- ["K024012"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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