FDA recall Z-2555-2025

Orthofix U.S. LLC · Class II · device

Product

PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

Reason for recall

A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.

Distribution

US Nationwide distribution in the states of CO, CA.

Key facts

Status
Ongoing
Initiation date
2025-06-24
Report date
2025-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lewisville, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2555-2025