FDAFDA recall Z-3226-2026 · Sep 30, 2026
SEASPINE ORTHOPEDICS CORPORATION: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head recall
Recall found
Product
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Reason for recall
The proximal thread depth of the spinal device is out of design specification.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
- Quantity
- 270 units
- 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.
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-19
Source: openFDA enforcement record Z-3226-2026 · search recall number Z-3226-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.