CLASS II Device recall · Reported 17 Feb 2016 · FDA Enforcement Report

Firebird Spinal Fixation System Torque Limiting Handle recalled

Orthofix is recalling Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for. The recall was initiated on 8 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBS535418105, BS535419118, BS535420030, BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039, BS535418127, BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and BS562325023.

Quantity recalled36 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-0797-2016
FDA event ID: 73069
Recalling firm: Orthofix, Lewisville, TX
Classification: Class II
Status: Terminated
Recall initiated: 8 Jan 2016
FDA classified: 10 Feb 2016
Reported: 17 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Spinal Implants

Timeline

8 Jan 2016	Recall initiated by company
10 Feb 2016	Classified by FDA	+33 days
17 Feb 2016	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

There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).

Where it was distributed

Worldwide Distribution -- US, Spain, Italy, and Australia.

Questions about this recall

Is Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for recalled?

Yes. Orthofix recalled Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for on 8 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-0797-2016.

Why was it recalled?

Which lots are affected?

BS535418105, BS535419118, BS535420030, BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039, BS535418127, BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and BS562325023.

Where was it sold?

Worldwide Distribution -- US, Spain, Italy, and Australia.

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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