Class II — SEASPINE ORTHOPEDICS CORPORATION
| Recalling firm | SeaSpine Orthopedics Corporation |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System |
| 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. |
| Initiated | 2025-08-06 |
| Classified | 2025-09-11 |
| Recall number | Z-2554-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SEASPINE ORTHOPEDICS CORPORATION (Z-2554-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97190/
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