Orthofix U.S. LLC recalls PILLAR SA Ti

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.

On 6/24/2025, recall notes were emailed to customers who were asked to do the following: 1) Examine your inventory and quarantine any affected product. 2) If implanted, healthcare Providers should determine whether it is necessary to inform the patient, based on clinical judgment and individual circumstances. 3) This notice should be shared with all relevant personnel within your organization and forwarded to any other organization or facility where potentially affected devices may have been transferred. 4) Complete and return the response form to the firm. Should you have any questions regarding this matter, please contact the firm at madison.ebel@seaspine.com

• FDA enforcement recordOfficial FDA database entry for Z-2555-2025
• FDA 510(k) clearance · K240749The device's official FDA premarket clearance record
• FDA device classification · MAXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3080The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Orthofix U.S. LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.