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

FDA Recall #Z-2554-2025 — Class II — August 6, 2025

Recall #Z-2554-2025 Date: August 6, 2025 Classification: Class II Status: Ongoing

Product Description

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

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.

Recalling Firm

SEASPINE ORTHOPEDICS CORPORATION — Carlsbad, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

74

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.

Code Information

UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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