SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head recall (SEASPINE ORTHOPEDICS CORPORATION)
Medical deviceClass IIOngoing
Summary: SEASPINE ORTHOPEDICS CORPORATION is recalling SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12. Reason: The proximal thread depth of the spinal device is out of design specification.
What is being recalled
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Why
The proximal thread depth of the spinal device is out of design specification.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, Virginia)
How to tell if yours is affected
UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3226-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 19, 2026 |
| Reported | September 30, 2026 |
| Company | SEASPINE ORTHOPEDICS CORPORATION |
| Company location | Carlsbad, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 270 units |
More recalls from SEASPINE ORTHOPEDICS CORPORATION · all medical device recalls · recalls from August 2026