Recall Z-0780-2007
Orthopedic Systems Inc · initiated February 14, 2007
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.
Codes / lots: Product Number 5979-300, listing 878.4950.
Reason for recall
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0780-2007
- Initiated
- February 14, 2007
- Posted by FDA
- May 4, 2007
- Terminated
- December 6, 2007
- Product code
- FWZ – Operating Room Accessories Table Tray
- Quantity
- 8 units distributed.
- Distribution
- The products were distributed to 8 consignees in the United States, to ID, IL, NY, and CA.
- Recalling firm
- Orthopedic Systems Inc, Union City, CA