Z-1749-2015Class II

ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium...

Name: Z-1749-2015 ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium...
Creator: Orthofix, Inc
Published: 2015-05-18
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2015-05-18 / Terminated / root cause: labeling and UDI

FDA source

Orthofix, Inc began a recall of 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 on 2015-05-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1749-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-18
Posted: 2015-06-10
Terminated: 2015-10-30
Recalling firm: Orthofix SRL
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
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: 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.
Quantity in commerce: 45 units
Distribution: US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.
Product codes and lots: Lot Number S29

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1749-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1749-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-10

Product code NKB

K130932Class IIFirebird Spinal Fixation SystemOrthofix, Inc. / cleared 2013-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)