medical Class II Updated 2025-04-02

Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusi

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: (1) REF 82-3300SP - Lot Number 001, UDI 18257200160426; (2) REF 82-3700SP - Lot Number 001, UDI 18257200160884; and (3) REF 82-4000SP - Lot Number 001, UDI 18257200161270.
View official government recall

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