# FDA recall Z-2554-2025

> **SEASPINE ORTHOPEDICS CORPORATION** · Class II · device recall initiated 2025-08-06.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-2554-2025
- **Recalling firm:** SEASPINE ORTHOPEDICS CORPORATION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-06
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2554-2025

## Citation

> AI Analytics. FDA recall Z-2554-2025. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2554-2025. Source: US FDA. Licensed CC0.

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