ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only P
FDA device recall Z-1749-2015 · posted 2015-06-10 · Terminated
Recall details
- Recalling firm
- Orthofix, Inc
- 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.
- 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.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 45 units
- Distribution
- US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.
- Date initiated
- 2015-05-18
- Date posted
- 2015-06-10
- Date terminated
- 2015-10-30
- Location
- Lewisville, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIREBIRD SPINAL FIXATION SYSTEM (K130932) | Orthofix, Inc. | 2013-08-07 |