SEASPINE ORTHOPEDICS CORPORATION: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

Is my product affected?

SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

• UPC 10889981257248

Check against the official notice below — it lists the full affected range.

Hazard

The proximal thread depth of the spinal device is out of design specification.

Details from the source

Reason for recall: The proximal thread depth of the spinal device is out of design specification. Distribution: 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. Quantity: 270 units Lot/code info: UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back Check Valve, 3 SmartSi2026-08-19
• NOxBOXi Nitric Oxide Delivery System.2026-08-19
• REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM2026-08-19
• REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM2026-08-19
• REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM2026-08-19

All FDA (Device enforcement) recalls