RecallRadar

FDA Device recall Z-2554-2025

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

On 2025-09-17 the FDA classified a Class II recall of Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System by Seaspine Orthopedics, citing 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 l….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2554-2025
ClassificationClass II
Statusongoing
Initiated2025-08-06
Published2025-09-17
Last updated2026-09-13 11:57 UTC
CompanySeaspine Orthopedics
DistributionUS

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2554-2025%22

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