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Orthofix, Inc recalls Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and
Recalled February 17, 2016 · FDA recall Z-0797-2016 · Orthofix
Hazard
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. · FDA Class II
Units
36 units
Sold at
Worldwide Distribution -- US, Spain, Italy, and Australia.
Description
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.
Product
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
Manufacturer(s)
Orthofix, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →