FDA Enforcement
Class II
Ongoing
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Recall: Z-2554-2025
·
Reported September 17, 2025
Enforcement
- Recall Number
- Z-2554-2025
- Event ID
- 97190
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SEASPINE ORTHOPEDICS CORPORATION
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 17, 2025
- Initiation Date
- August 6, 2025
- Classification Date
- September 11, 2025
- Address
- 5770 Armada Dr, N/A, Carlsbad, CA, 92008-4608, United States
Description
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.
Code Info
UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2
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.
Quantity
74