Z-0780-2007

Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which...

Name: Z-0780-2007 Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which...
Creator: Orthopedic Systems Inc
Published: 2007-02-14
License: https://open.fda.gov/license/

Mizuho Orthopedic Systems Inc / initiated 2007-02-14 / Terminated / root cause: manufacturing process

FDA source

Orthopedic Systems Inc began a recall of 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... on 2007-02-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0780-2007
Status: Terminated
Initiated: 2007-02-14
Posted: 2007-05-04
Terminated: 2007-12-06
Recalling firm: Mizuho 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.
Product code: FWZ Operating Room Accessories Table Tray
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 8 units distributed.
Distribution: The products were distributed to 8 consignees in the United States, to ID, IL, NY, and CA.
Product codes and lots: Product Number 5979-300, listing 878.4950.

Product code FWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)