FDA-Device2016-02-17Class II
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
Orthofix, Inc
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.
Sold states
Worldwide Distribution -- US, Spain, Italy, and Australia.
Affected count
36 units
Manufactured in
3451 Plano Pkwy, N/A, Lewisville, TX, United States
Products
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2016Don't want to check this manually?
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