Recall Z-0780-2007 ยท FWZ Operating Room Accessories Table Tray
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.
| Date | May 4, 2007 (initiated Feb 14, 2007) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.