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Wiltrom Spinal Fixation System

WILTROM CO., LTD. · Model 43517045 Polyaxial Pedicle Screw ø=7.0 L=45 · UDI-DI 04712928178384

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510(k) clearances

24,647

Adverse events (86 deaths)

181

Recalls

409

Facilities

Description

The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.

Recalls

Date	Firm	Reason
2026-05-28	SEASPINE ORTHOPEDICS CORPORATION	Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
2026-05-22	Innovasis, Inc	Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with unde
2025-09-19	Orthofix U.S. LLC	Polyaxial screws do not meet performance standards.
2025-06-30	SPINEART SA	Cannulated fenestrated polyaxial screws may be incorrectly labeled
2025-06-30	SPINEART SA	Cannulated fenestrated polyaxial screws may be incorrectly labeled
2024-10-29	SEASPINE ORTHOPEDICS CORPORATION	Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
2024-10-29	SEASPINE ORTHOPEDICS CORPORATION	Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
2024-08-21	XTANT Medical Holdings, Inc	Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and
2024-03-15	SPINEART SA	Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The
2024-02-28	SEASPINE ORTHOPEDICS CORPORATION	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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.