Reported Feb 17, 2016 · Terminated
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and…
Orthofix, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix, Inc · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
- Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
- Lot codes and dates
BS535418105BS535419118BS535420030BS535419124BS562325021BS535418158BS535418038BS535418138BS535418012BS535419006BS535420039BS535418127BS549024010BS535419141BS535418081BS535418111BS535418117BS535420041BS535418144BS535420081BS535419151BS562325006BS546825008BS535418002BS535418013BS535418131BS535420006BS535420010BS535420026BS535420047BS556219012BS556219026BS535418109BS535420082BS557717009and BS562325023
- Amount recalled
- 36 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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