ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
This recall has been terminated (originally issued June 10, 2015).
- Company
- Orthofix, Inc
- Recall Initiated
- May 18, 2015
- Posted
- June 10, 2015
- Terminated
- October 30, 2015
- Recall Number
- Z-1749-2015
- Quantity
- 45 units
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.
Distribution
US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.
Lot / Code Info
Lot Number S29
Root Cause
Unknown/Undetermined by firm
Action Taken
Orthofix sent an Urgent Medical Device Recall Notification letter dated May 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Affected customers were instructed to inspect their inventory, and identify and remove the recalled product to send back to Orthofix. The distributors are also instructed to provide recall notification to hospitals, surgeons, or other distributors that they have further distributed affected product to. Contact your local Orthofix representative or Orthofix customer service representative at 888-298-5700 for return instructions and shipment information.