SeaSpine Mariner Deformity Spinal Device Recall Due to Thread Depth Issue
SeaSpine Orthopedics is recalling 270 units of the Mariner Deformity Extended Polyaxial Head because the proximal thread depth is out of design specification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural deviation (thread depth out of specification) in a spinal implant, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
SeaSpine Orthopedics Corporation is recalling 270 units of the SeaSpine Mariner Deformity Extended Polyaxial Head, Attached Gimbal, 12mm (REF: MD1-300010-12). The recall was initiated because the proximal thread depth of the spinal device is out of design specification.
The affected product was distributed nationwide in the United States, specifically in Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia. The recall includes specific lots identified by UDI-DI 10889981257248 and lot numbers TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, and TE142282D.
Healthcare providers and patients should contact SeaSpine Orthopedics Corporation for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 270
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UDI-DI 10889981257248
- Affected Lots: TE145060D
- TE170356F
- TE170556F
- TE165793F
- TE145059E
- TE161254F
- TE142282D.
Distribution
Related recalls
Same manufacturer · SEASPINE ORTHOPEDICS CORPORATION
See all →- HighSeaSpine Polyaxial Head Recalled Due to Potential Intraoperative Dislodgement
FDA (Devices) · 2026-07-29
- ModerateSpinal navigation guide recalled for naming an incompatible toolcard system
FDA (Devices) · 2025-12-24
- HighSpinal inserters recalled over difficulty disengaging implants and incorrect UDI marking
FDA (Devices) · 2025-09-17
- HighDaytona Small Stature Locking Caps recalled for manufacturing defects
FDA (Devices) · 2025-01-01
- HighFDA Recalls Medical Spine Component Due to Manufacturing Defects
FDA (Devices) · 2025-01-01
Same hazard · structural defect
See all →- SeverePi-Cardia ShortCut Transfemoral Catheter Recalled for Detachment Risk
FDA (Devices) · 2026-09-23
- HighForest River Recalls 2026-2027 Dynamax Isata RVs Due to Ladder Defect
NHTSA · 2026-09-23
- Severe
- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- HighLight Boy Recalls GBX12SK Light Towers Due to Frame Bending Risk
NHTSA · 2026-09-01
Similar recalls
- HighSeaSpine Polyaxial Head Recalled Due to Potential Intraoperative Dislodgement
FDA (Devices) · 2026-07-29
- HighMariner RDX Pedicle Screw Heads Recalled for Intraoperative Cross-Threading Risk
FDA (Devices) · 2024-05-01
- HighPedicle Screw Heads Recalled Due to Cross-Threading Risk During Surgery
FDA (Devices) · 2024-05-01
- SevereDePuy Spine VIPER Polyaxial Screws Recalled for Potential Disassociation
FDA (Devices) · 2013-01-30
- SevereDePuy Spine VIPER Polyaxial Screw Recall for Potential Disassociation
FDA (Devices) · 2013-01-30
- SevereDePuy Spine VIPER Polyaxial Screws Recalled for Potential Separation
FDA (Devices) · 2013-01-30