Drug recall
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The…
FDA recall event 78181 · Class II · Genesys Orthopedics Systems, LLC
Key facts
| Event ID | 78181 |
|---|---|
| Recall numbers | Z-0040-2018 |
| Recalling firm | Genesys Orthopedics Systems, LLC |
| Product type | Devices |
| Products | Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off. |
| Initiation date | Nov 5, 2015 |
| Report date | Oct 25, 2017 |
| Termination date | Jul 19, 2018 |
| City | West Lake Hills |
| State | TX |
| Country | United States |
| FEI number | 3008455034 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: