Device product
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
Z-1749-2015
Product summary
- Firm
- Orthofix, Inc
- Event
- Event 71297
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 units
- Official record key
device-enforcement:Z-1749-2015
Official wording
Reason: 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.
Code information: Lot Number S29
Distribution pattern: US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.
Derived failure modes
-
Labeling or packaging
mislabeled