CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report

Firebird Spinal Fixation System Multi-Axial Screw recalled by Orthofix

Orthofix is recalling Orthofix Firebird Spinal Fixation System Multi-Axial Screw, Standard Implant Grade, distributed nationwide in the US. The recall was initiated on 18 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number S29

Quantity recalled45 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1749-2015
FDA event ID: 71297
Recalling firm: Orthofix, Lewisville, TX
Classification: Class II
Status: Terminated
Recall initiated: 18 May 2015
FDA classified: 10 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Spinal Implants

Timeline

18 May 2015	Recall initiated by company
10 Jun 2015	Classified by FDA	+23 days
17 Jun 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.

Nationwide California Colorado Florida Maryland Michigan New York Oklahoma Pennsylvania South Carolina

Questions about this recall

Is Firebird Spinal Fixation System Multi-Axial Screw, Standard Implant Grade Titanium Alloy recalled?

Yes. Orthofix recalled Firebird Spinal Fixation System Multi-Axial Screw, Standard Implant Grade Titanium Alloy on 18 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1749-2015.

Why was it recalled?

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.

Which lots are affected?

Lot Number S29

Where was it sold?

US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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