FDA Medical devices recall ·
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head… recall
- Recall number
- Z-3226-2026
- Date
- (initiated August 19, 2026)
- Company / brand
- Seaspine Orthopedics Corporation
5770 Armada Dr, Carlsbad, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 270 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Why was it recalled?
The proximal thread depth of the spinal device is out of design specification.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Alabama California Colorado Connecticut Florida Georgia Massachusetts Michigan Minnesota Missouri North Carolina Nevada New York Oklahoma Oregon Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3226-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.