Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Seaspine Orthopedics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SEASPINE ORTHOPEDICS CORPORATION · 5770 Armada Dr · Carlsbad, CA · 92008-4608
Is this the product you have?
- SeaSpine Mariner Deformity Product NameExtended Polyaxial Head, Attached Gimbal, 12mm
- REFMD1-300010-12
- Lot codes and dates
- UDI-DI 10889981257248
- Affected Lots
TE145060DTE170356FTE170556FTE165793FTE145059ETE161254FTE142282D
- Amount recalled
- 270 units
Where it was sold
Why it was recalled
The proximal thread depth of the spinal device is out of design specification.
This product could cause temporary or reversible health problems — stop using it.
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