SEASPINE ORTHOPEDICS CORPORATION recalls Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System

Recall date

August 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2554-2025

FDA classification

Class II

Brand / firm

SEASPINE ORTHOPEDICS CORPORATION

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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