HIGH

SEASPINE Orthopedics Recalls Surgical Inserter Over Implant Risks

SEASPINE Orthopedics recalled 74 units of the Reef TA Inserter on August 6, 2025. The device may cause difficulties in disengaging implants, leading to prolonged surgeries. Healthcare providers should stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
August 6, 2025
Hazard Level
HIGH
Brand
SEASPINE ORTHOPEDICS
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEASPINE ORTHOPEDICS CORPORATION or your healthcare provider for instructions. Notification method: Letter

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Product Details

The Reef TA Inserter, Part Number: TA2-001003, is part of the Reef Interbody System. The recalled devices were distributed worldwide, including in 15 U.S. states and Hong Kong.

The Hazard

The inserter may cause difficulty disengaging the implant or improper positioning during surgery. This may lead to prolonged surgery times and the need for alternative instruments.

What to Do

Stop using the Reef TA Inserter immediately. Contact SEASPINE ORTHOPEDICS CORPORATION or your healthcare provider for recall instructions.

Contact Information

For more information, visit the FDA page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2554-2025 or contact SEASPINE directly.

Key Facts

  • Recalled product: Reef TA Inserter, Part Number: TA2-001003
  • Quantity recalled: 74 units
  • Recall date: August 6, 2025
  • High hazard level due to surgical risks
  • Immediate stop-use instructions issued

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
UDI-DI: 10889981290733
10889981437800
BT107376C
BT112289C
BT112779C
+5 more
Affected States
ALL
Report Date
September 17, 2025
Recall Status
ACTIVE

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