SeaSpine Mariner Deformity Extended Polyaxial Head
The spinal device has a thread depth out of design specification.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Seaspine ORTHOPEDICS CORPORATION began the recall on August 19, 2026, of the Seaspine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm because the proximal thread depth of the spinal device is out of design specification. The FDA added the recall to its Enforcement Report and classified it on September 18, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
- UDI-DI
- 10889981257248
- Lot
- TE145060D
- TE170356F
- TE170556F
- TE165793F
- TE145059E
- TE161254F
- TE142282D
Details
- Company began the recall
- Sold in
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.
- Event ID
- 99691
- Recall No.
- Z-3226-2026
- Company
- SEASPINE ORTHOPEDICS CORPORATIONCarlsbad, California
- Hazard
- Device defect
- Quantity recalled
- 270 units
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
