FDA-Device2025-09-17Class II
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
SEASPINE ORTHOPEDICS CORPORATION
Hazard
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.
Sold states
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.
Affected count
74
Manufactured in
5770 Armada Dr, N/A, Carlsbad, CA, United States
Products
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2554-2025Don't want to check this manually?
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