Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Doro Adapter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Doro Adapter see related information
Date Initiated by Firm February 14, 2007
Date Posted May 04, 2007
Recall Status1 Terminated 3 on December 06, 2007
Recall Number Z-0780-2007
Recall Event ID 37510
Product Classification surgical table patient support - Product Code FWZ
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.
Code Information Product Number 5979-300, listing 878.4950.
Recalling Firm/
Manufacturer		 Orthopedic Systems Inc
30031 Ahern Ave
Union City CA 94587-1234
Manufacturer 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 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-