FDA-Device2026-09-30Class IIPROCESSING DEFECT
SeaSpine Mariner Deformity spinal device recalled for out-of-specification thread depth
What this means
SeaSpine Orthopedics is recalling certain Extended Polyaxial Head spinal implants (model MD1-300010-12) because the proximal thread depth does not meet design specifications. This defect could affect the secure attachment of the device during spinal surgery. No injuries have been reported.
- If you received this implant, contact your surgeon or healthcare provider immediately
- Check the product lot number (TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, or TE142282D) on your implant records
- Do not use affected units; return them to SeaSpine or your medical facility
The agency's original wording
Hazard
The proximal thread depth of the spinal device is out of design specification.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
270 units
Manufactured in
5770 Armada Dr, Carlsbad, CA, United States
Products
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3226-2026More SeaSpine recalls
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