FDA Recall
Terminated
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: Z-0780-2007
·
Initiated February 14, 2007
Recall
- Recall Number
- Z-0780-2007
- Event Number
- 37510
- Firm
- Orthopedic Systems Inc
- FEI Number
- 2921578
- Product Code
- FWZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 14, 2007
- Posted
- May 4, 2007
- Terminated
- December 6, 2007
- Address
- 30031 Ahern Ave, Union City, CA, 94587-1234
Description
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.
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.
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.
Distribution
The products were distributed to 8 consignees in the United States, to ID, IL, NY, and CA.
Quantity
8 units distributed.