Orthofix U.S. LLC: 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

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of California, Colorado, and Missouri. Quantity: 20 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.

UPC codes

18257200160426, 18257200160884, 18257200161270

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.