Orthofix product recalled over fire hazard

Recall date

January 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Orthofix, Inc recalls Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and n…

Recall number

Z-0797-2016

FDA classification

Class II

Brand / firm

Orthofix, Inc

Sold / distributed

Worldwide Distribution -- US, Spain, Italy, and Australia.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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