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FDAJanuary 8, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

orthofix

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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