Reported Sep 17, 2025 · Ongoing

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

Seaspine Orthopedics Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SEASPINE ORTHOPEDICS CORPORATION · 5770 Armada Dr · Carlsbad, CA · 92008-4608

Is this the product you have?

  • Reef TA Inserter
  • Part NumberTA2-001003, part of the Reef Interbody System
Lot codes and dates
  • UDI-DI
    • 10889981290733
    • 10889981437800
  • Lots
    • BT107376C
    • BT112289C
    • BT112779C
    • BT107376CR1
    • BT107376CR2
    • BT107376CR1R2
    • BT112289CR2
    • BT112779CR2
Amount recalled
74

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:24 PM UTC

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