Recall Register

SEASPINE ORTHOPEDICS CORPORATION: FDA recalls

FDA enforcement events from 2024 to 2026; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name SEASPINE ORTHOPEDICS CORPORATION as the recalling firm in 9 events. The events have 11 product records. The recalls started from 2024 to 2026. All the events are device recalls. By FDA enforcement events, SEASPINE ORTHOPEDICS CORPORATION is number 386 of 1,628 firms that have a page. Events that SEASPINE ORTHOPEDICS CORPORATION started: 5 in 2024 and 2 in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 100.0% of its events and 73.7% of all FDA events.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

9 events, newest first.

FDA enforcement events of SEASPINE ORTHOPEDICS CORPORATION
InitiatedProduct (first record)TypeClassRecordsStatus
19 Aug 2026SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12DeviceClass II1Ongoing
28 May 2026SeaSpine Polyaxial Head REF Number: 41-3010DeviceClass II1Ongoing
17 Nov 2025Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5.5mm Drill, REF:…DeviceClass II1Ongoing
6 Aug 2025Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody SystemDeviceClass II1Ongoing
29 Oct 2024Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: NoDeviceClass II2Ongoing
4 Jun 2024Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: NoDeviceClass II1Ongoing
17 May 2024Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor bladeDeviceClass II2Ongoing
28 Feb 2024Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.DeviceClass II1Ongoing
15 Feb 2024Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha…DeviceClass II1Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

SEASPINE ORTHOPEDICS CORPORATION: events for each product type
TypeEvents
Device9
SEASPINE ORTHOPEDICS CORPORATION: events in each class
ClassEvents
Class II9
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
9

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of SEASPINE ORTHOPEDICS CORPORATION, by the year that the recall started. The largest year is 2024, with 5 events.

Official channels

Cite this page

Recall Register. SEASPINE ORTHOPEDICS CORPORATION: FDA recalls. https://recallregister.com/firm/seaspine-orthopedics-corporation/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of SEASPINE ORTHOPEDICS CORPORATION have?
Class II: 9 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of SEASPINE ORTHOPEDICS CORPORATION?
FDA event 99691, which the firm started on 19 Aug 2026. The first product in the record is: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
How many FDA recalls of SEASPINE ORTHOPEDICS CORPORATION have the status Ongoing?
9 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.