SEASPINE ORTHOPEDICS CORPORATION: Medical Device Recall in 2025 - (Recall #: Z-2554-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 6, 2025

Date Posted: September 17, 2025

Recall Number: Z-2554-2025

Event ID: 97190

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.

Status: Ongoing

Product Quantity: 74

Code Information:

UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated