FDAFDA · Food and drugs·Recall number Z-3226-2026
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Published September 30, 2026 · Recall initiated: August 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The proximal thread depth of the spinal device is out of design specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Distributor
- US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia.
- Lot
- UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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Questions about this recall
Was SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12 recalled?
Yes. FDA published recall Z-3226-2026 on September 30, 2026. Reported hazard: The proximal thread depth of the spinal device is out of design specification.
What should I do if I have this product?
Voluntary: Firm initiated · Letter
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