SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
SeaSpine recalls specific Mariner Deformity products due to proximal thread depth being out of design specs. Affected units include model MD1-300010-12 with certain lot numbers. No remedy provided in official notice.
Recall notice
The proximal thread depth of the spinal device is out of design specification.
What happened, in plain English
SeaSpine is recalling specific Mariner Deformity products because the spinal device's thread depth is not as designed. This could lead to improper function or injury during medical procedures. Affected units have specific lot numbers and model references. Read more at govinfonow.com/recall/1292593-seaspine-mariner-deformity-product-recall-thread-depth-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/1292593-seaspine-mariner-deformity-product-recall-thread-depth-issue · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3226-2026
Cite this page
“SeaSpine Mariner Deformity Product Recall: Thread Depth Issue.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292593-seaspine-mariner-deformity-product-recall-thread-depth-issue. Based on FDA recall #Z-3226-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3226-2026%22&limit=1).
Why it’s dangerous
The proximal thread depth of the spinal device is out of design specification. This could cause improper alignment or function during surgery, potentially leading to complications. However, the exact risk level is not clearly described in the recall notice.
Who’s affected
Orthopedic surgeons and medical professionals using SeaSpine Mariner Deformity products are most at risk. Patients receiving these devices during surgery may be affected if the product is used without proper specifications.
How to tell if you have this one
Check for the model number MD1-300010-12 and lot numbers TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D on the product packaging or documentation.
- Brand
SeaSpine- Category
Medical device
What to do — step by step
Check Product Details
Identify the model number and lot numbers listed in the product documentation to confirm if it is affected.
Questions people ask
Is there a fix for this product?
The official recall notice does not provide a remedy for this product.
What should I do if I have this product?
The recall notice does not specify any action steps for affected products.
How can I confirm if my product is affected?
Check the product for the model number MD1-300010-12 and lot numbers TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
Contact SeaSpine
We’ve drafted a message you can send SeaSpine to request your refund or repair — edit it as you like.
Subject: Recall Z-3226-2026 — SeaSpine SeaSpine Hello, I own a SeaSpine that is covered by recall Z-3226-2026 from SeaSpine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3226-2026 (August 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3226-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.