Orthofix, Inc: Medical Device Recall in 2016 - (Recall #: Z-0797-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 8, 2016

Date Posted: February 17, 2016

Recall Number: Z-0797-2016

Event ID: 73069

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.

Status: Terminated

Product Quantity: 36 units

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated