Device recall
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
- Recall number
- Z-3226-2026
- Event id
- 99691
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Aug 19, 2026
- Center classification date
- Sep 18, 2026
- Product code
- NKB
- Device type
- Thoracolumbosacral Pedicle Screw System
- Reason
- The proximal thread depth of the spinal device is out of design specification.
- Root cause
- Process design
- Quantity
- 270 units
- Code info
- UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K211606
- Location
- Carlsbad, CA, United States