FDA Device recall Z-3226-2026
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12 by Seaspine Orthopedics, citing the proximal thread depth of the spinal device is out of design specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3226-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-19 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Seaspine Orthopedics |
| Distribution | US |
Product
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Reason
The proximal thread depth of the spinal device is out of design specification.
Identifiers
| code_info | UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
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- SeaSpine Polyaxial Head REF Number: 41-3010
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3226-2026%22
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