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System, Facet Screw Spinal Device
FDA product code MRW · Class U · Unknown
2,413
Registered devices
105
Adverse events
4
Recalls
79
510(k) clearances
Devices with this code
Vectre — QUANDARY MEDICAL LLCUCSS® Screw Set — MEDTRONIC SOFAMOR DANEK, INC.ION Facet Screw System — Surgentec, LLCFaset — DIOMEDICAL CO.,LTD.OASYS — Stryker CorporationConcero™ Facet Screw System — BIOMET SPINE LLCFS3 Facet Screw Spinal System — Life Spine, Inc.FacetFuse® — SPINEFRONTIER, INC.CONCERO FACET SCREW SYSTEM — BIOMET SPINE LLCFacetBRIDGE — LDR Spine Usa, Inc.FacetFuse® — SPINEFRONTIER, INC.FS3 Facet Screw Spinal System — Life Spine, Inc.FacetFuse® — SPINEFRONTIER, INC.CONCERO FACET SCREW SYSTEM — BIOMET SPINE LLCOASYS — Stryker CorporationUCSS® Screw Set — MEDTRONIC SOFAMOR DANEK, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.CONCERO FACET SCREW SYSTEM — BIOMET SPINE LLCFacetFuse® — SPINEFRONTIER, INC.CORRIDOR — GLOBUS MEDICAL, INC.ION Caddy with Metal Plate — Surgentec, LLCFacetFuse® — SPINEFRONTIER, INC.TOWNLEY™ Transfacetpedicular Screw Fixation System — MEDTRONIC SOFAMOR DANEK, INC.Concero™ Facet Screw System — BIOMET SPINE LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-27 | Medtronic Sofamor Danek USA, Inc | Product is impacted by a thread profile defect due to a manufacturing issue. |
| 2011-06-07 | Osteomed, Lp | Two of the Implant Driver Assembly tips were reported to break during surgery. |
| 2011-03-15 | Interventional Spine Inc | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed wit |
| 2011-03-15 | Interventional Spine Inc | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed wit |
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