Recall Z-2554-2025— SEASPINE ORTHOPEDICS CORPORATION
Class II · Ongoing
Class II FDA medical device recall by SEASPINE ORTHOPEDICS CORPORATION, initiated 2025-08-06. It names one FDA 510(k) clearance: K192132. 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..
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-06
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.