Orthofix—Axial and Parallel Rod Connectors Used with Firebird Spinal Fixation Systems: Set Screw Component May Crack during Final Tightening

Action Needed:

​Verify ​that you have received the February 1, 2013, Urgent Medical Device Recall Notification letter, return instructions, Dear Doctor letter, and tracking and verification form from Orthofix. Identify and isolate any affected product in your inventory. Return affected product to Orthofix using the product return instructions. Regardless of whether you have affected product, complete the tracking and verification form and return it to Orthofix by fax using the information on the form. Provide a copy of the Dear Doctor letter to any facility to which you have further distributed affected product. U.S. customers should report serious adverse events or product quality problems relating to the use of affected product to FDA’s MedWatch Adverse Event Reporting program by telephone at (800) 332-1088![]( "Call: (800) 332-1088"); by fax at (800) 332-0178![]( "Call: (800) 332-0178"); by mail (using postage-paid FDA Form 3500, available here) at Food...