Facility

SEASPINE ORTHOPEDICS CORPORATION

9 recall(s) on record — most severe on record: Class II.

Key facts

9recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012120772
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	5770 Armada Dr Carlsbad, CA, US 92008
Registration status	Active · expires 2026
Parent company	SeaSpine Orthopedics Corporation (owner-operator 10049589)
Brand names	UCR; Malibu

Activity by year

Recalls (9)
Inspections (2)

Devices registered here (1)

Fork
Product code HXE (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

Recalls & enforcement

Class IIOngoing2026-08-19
The proximal thread depth of the spinal device is out of design specification.
Class IIOngoing2026-05-28
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Class IIOngoing2025-11-17
The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for u…
Class IIOngoing2025-08-06
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentat…
Class IIOngoing2024-10-29
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Class IIOngoing2024-06-04
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Class IIOngoing2024-05-17
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Class IIOngoing2024-02-28
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Class IIOngoing2024-02-15
Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

FDA inspections (2)

NAI2022-04-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-08-14
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SEASPINE ORTHOPEDICS CORPORATION (FEI 3012120772) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012120772-seaspine-orthopedics-corporation/

Not open yet

Alerts for SEASPINE ORTHOPEDICS CORPORATION

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.