Recall Register

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SEASPINE ORTHOPEDICS CORPORATION

FDA recalling firm · 8 enforcement events · 10 product records · 2024–2026 · CA

SEASPINE ORTHOPEDICS CORPORATION has 8 FDA enforcement events on this register (10 product records) between 2024 and 2026: 8 device; the busiest year was 2024 with 5.

0% of its events are Class I; the most common class is Class II (8). 8 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
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

By type and class

Device8
Class II8

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

24
25
26
Enforcement events for SEASPINE ORTHOPEDICS CORPORATION by year initiated.

Questions and answers

How many FDA recalls has SEASPINE ORTHOPEDICS CORPORATION had?

8 enforcement events (10 product records) on this register, 2024–2026: 8 device.

Are any SEASPINE ORTHOPEDICS CORPORATION recalls ongoing?

8 events are listed as ongoing in the current openFDA export.

What class are SEASPINE ORTHOPEDICS CORPORATION recalls?

8 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.