Recall Z-1749-2015— Orthofix, Inc
Class II · Terminated
Class II FDA medical device recall by Orthofix, Inc, initiated 2015-05-18, terminated 2015-10-30. It names one FDA 510(k) clearance: K130932. 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. 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..
- Recalling firm
- Orthofix, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-18
- Terminated
- 2015-10-30
- Firm location
- Lewisville, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.