SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head
- Recalling company
- SEASPINE ORTHOPEDICS CORPORATION
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 19, 2026
- Reported
- Sep 30, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 270 units
- Lot / codes
- UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
- Company location
- Carlsbad, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3226-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3226-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.