Z-0797-2016Class II

Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical...

Name: Z-0797-2016 Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical...
Creator: Orthofix, Inc
Published: 2016-01-08
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2016-01-08 / Terminated / root cause: design

FDA source

Orthofix, Inc began a recall of Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium) on 2016-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0797-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-08
Posted: 2016-02-11
Terminated: 2016-11-16
Recalling firm: Orthofix SRL
Product: Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
Product code: HXC Wrench
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Affected consignees were notified via an Urgent Medical Device Recall Notification letter, dated 1/8/16. The letter identified the affected device and stated the reason for the recall. The recalling firm requests customers to remove the affected devices from their inventory and cease further distribution or use. Customers whom the devices were further distributed to should be notified that the affected devices cannot be used and must be returned to Orthofix per the instructions provided. The attached Acknowledgement Form should be completed and returned. Customers can contact their local Orthofix representative or customer service for further information, replacements, or disposal instructions.
Quantity in commerce: 36 units
Distribution: Worldwide Distribution -- US, Spain, Italy, and Australia.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0797-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0797-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-10

Product code HXC

K151488Class IIFirebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. / cleared 2015-07-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)