SEASPINE ORTHOPEDICS CORPORATION recalls Reef TA Inserter

Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.

On 8/6/2025, recall notices were emailed to customers and distributors who were informed of the following: A laser marking error was identified in which the TA2-001003 inserters were incorrectly marked with the UDI-DI for model TA2-001002 (10889981290733). Updated Revision E Inserters have been shipped to you via overnight delivery. Kindly replace all existing Revision C/R1/R2 Inserters with the enclosed Revision E units. Return the Revision C Inserters to the recalling firm using provided RGA and prepaid shipping label. This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Should you have any questions regarding this matter, please contact the firm at: dominiquepetach@orthofix.com

• FDA enforcement recordOfficial FDA database entry for Z-2554-2025
• FDA 510(k) clearance · K192132The 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 SEASPINE ORTHOPEDICS CORPORATIONSearch 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.