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CORUS™ Spinal System

Providence Medical Technology, Inc. · Model DX-22-100 · UDI-DI 00852776006430

HRX Prescription

510(k) clearances

25,912

Adverse events (36 deaths)

126

Recalls

389

Facilities

Description

The CORUS Spinal System instruments are used to access and prepare the posterior cervical spine for joint fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of allograft or autograft in patients with or without anterior or posterior instrumentation. It is recommended that commercially available autograft or allograft be used to aid fusion. Autograft or allograft material is not supplied as part of the system.

Recalls

Date	Firm	Reason
2025-02-11	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may
2024-10-11	Karl Storz Endoscopy	Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
2024-05-24	WOM World Of Medicine AG	Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2021-05-17	ADRIA SRL	The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
2021-05-17	ADRIA SRL	The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
2021-05-17	ADRIA SRL	The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
2021-01-19	ReNovo, Inc.	Non-sterile product was shipped to customers labelled as sterile.
2020-06-24	Smith & Nephew, Inc.	The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
2020-04-24	Medtronic Sofamor Danek USA Inc	Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may incre

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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.