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.
FDA Recall Z-0780-2007 · Posted 2007-05-04
Recalling FirmOrthopedic Systems Inc
Recall StatusTerminated
Product CodeFWZ
Date Initiated2007-02-14
Date Terminated2007-12-06
Product Quantity8 units distributed.
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.
Firm 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.
Root Cause
Other
Distribution Pattern
The products were distributed to 8 consignees in the United States, to ID, IL, NY, and CA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.