Class II

Medical Device Recall: Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System

SEASPINE ORTHOPEDICS CORPORATION · August 6, 2025

Reason for Recall

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.

Distribution

Worldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and the country of Hong Kong.

States Affected

NATIONWIDE

Quantity Affected

74

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2554-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.