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FDAFebruary 20, 2025device

Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees.

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

The hazard

The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.

What to do

FDA enforcement status: Ongoing

Brands named

orthofix u sorthofix

UPCs

182572001604261825720016088418257200161270

Recall history

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

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