SEASPINE Orthopedics recalled 74 units of the Reef TA Inserter on August 6, 2025. The device may cause difficulties in disengaging implants, leading to prolonged surgeries. Healthcare providers should stop using the device immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEASPINE ORTHOPEDICS CORPORATION or your healthcare provider for instructions. Notification method: Letter
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The Reef TA Inserter, Part Number: TA2-001003, is part of the Reef Interbody System. The recalled devices were distributed worldwide, including in 15 U.S. states and Hong Kong.
The inserter may cause difficulty disengaging the implant or improper positioning during surgery. This may lead to prolonged surgery times and the need for alternative instruments.
No specific injury counts were reported, but the potential risks include intraoperative revisions and extended procedures.
Stop using the Reef TA Inserter immediately. Contact SEASPINE ORTHOPEDICS CORPORATION or your healthcare provider for recall instructions.
For more information, visit the FDA page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2554-2025 or contact SEASPINE directly.
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