Drug recall
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion…
FDA recall event 84350 · Class II · Trilliant Surgical, LLC
Key facts
| Event ID | 84350 |
|---|---|
| Recall numbers | Z-0799-2020 |
| Recalling firm | Trilliant Surgical, LLC |
| Product type | Devices |
| Products | Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as… |
| Initiation date | Mar 14, 2019 |
| Report date | Jan 22, 2020 |
| Termination date | Mar 16, 2022 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 3007420745 |
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: