SEASPINE ORTHOPEDICS CORPORATION — Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 6, 2025
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.
What's affected?
- Product
- Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
- Lot code
- BT107376C
Additional details
UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 74.
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