FDA recall Z-1432-2025

Orthofix U.S. LLC · Class II · device

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-02-20
Report date
2025-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lewisville, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1432-2025