PlainRecalls
FDA Devices Moderate Class II Ongoing

Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System

Reported: September 17, 2025 Initiated: August 6, 2025 #Z-2554-2025

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.

Details

Units Affected
74
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.
Location
Carlsbad, CA

Frequently Asked Questions

What product was recalled?
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System. Recalled by SEASPINE ORTHOPEDICS CORPORATION. Units affected: 74.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 17, 2025. Severity: Moderate. Recall number: Z-2554-2025.