Reef TA Inserter — Class II medical device recall Z-2554-2025
Ongoing recall by SEASPINE ORTHOPEDICS CORPORATION, reported 2025-09-17, distributed nationwide. Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty dis
| Recall number | Z-2554-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA, United States |
| Recall initiated | 2025-08-06 |
| Classified | 2025-09-11 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK |
| Quantity | 74 |
| UPC / GTIN / UDI-DI | 10889981290733, 10889981437800 |
| Lot numbers | BT107376C, BT107376CR1, BT107376CR1R2, BT107376CR2, BT112289C, BT112289CR2, BT112779C, BT112779CR2 |
| Model numbers | TA2-001003 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2554-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.