Seaspine Orthopedics Corporation

Complete recall history across all FDA and CPSC categories — 9 total recalls

Seaspine Orthopedics Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Seaspine Orthopedics Corporation

Date Product Reason Class
Nov 17, 2025 Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: ... The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly ident... Class II
Aug 6, 2025 Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System Inserter, used as part of a system with an intervertebral body fusion device,... Class II
Oct 29, 2024 Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small ... Due to manufacturing defects observed on Locking Caps that affect the ability... Class II
Oct 29, 2024 Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small... Due to manufacturing defects observed on Locking Caps that affect the ability... Class II
Jun 4, 2024 Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/... Insufficient weld around the cap component of the instrument is insufficient... Class II
May 17, 2024 Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm ... Cranial Caudal Blades manufactured incorrectly could result in fracture and/o... Class II
May 17, 2024 Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm ... Cranial Caudal Blades manufactured incorrectly could result in fracture and/o... Class II
Feb 28, 2024 Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alph... Screw heads, of pedicle screw systems, have partial thread within the screw h... Class II
Feb 15, 2024 Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial ... Screw heads, of pedicle screw systems, have thin lead-in thread that pose a r... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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