FDA Device recall Z-2554-2025
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System by Seaspine Orthopedics, citing 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 l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2554-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-06 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Seaspine Orthopedics |
| Distribution | US |
Product
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Reason
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.
Identifiers
| code_info | UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2554-2025%22
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