Devices

Device Recall Firebird Spinal Fixation System

Model / Serial
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.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- US, Spain, Italy, and Australia.
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).
Manufacturer
Orthofix, Inc
1 Event
- Recall of Device Recall Firebird Spinal Fixation System

Manufacturer

Orthofix, Inc

Manufacturer Address
Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
Manufacturer Parent Company (2017)
Orthofix International Nv
Source
USFDA

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