FDA Medical Device Recalls (openFDA)
Orthopedic Systems Inc: Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery.
- Recall number
- Z-0780-2007
- Recalling firm
- Orthopedic Systems Inc
- Product
- Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery.
- Status
- Terminated
- Initiated
- 2007-02-14
- Posted
- 2007-05-04
- Terminated
- 2007-12-06
- Reason
- Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue.
- Root cause
- Other
- Action
- A notification letter was sent to all 8 consignees on 02/16/2007. The firm will send service representatives to review any devices on site and replace with the proper part if needed.
- Quantity
- 8 units distributed.
- Distribution
- The products were distributed to 8 consignees in the United States, to ID, IL, NY, and CA.
- Lot, serial or model codes
- Product Number 5979-300, listing 878.4950.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FWZ
- Firm FEI
- 2921578
- Firm city
- Union City
- Firm state
- CA
- 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