Drug recall
Optimus Fixed Awl
FDA recall event 75856 · Class II · Amendia, Inc
Key facts
| Event ID | 75856 |
|---|---|
| Recall numbers | Z-0891-2017 |
| Recalling firm | Amendia, Inc |
| Product type | Devices |
| Products | Optimus Fixed Awl |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints that the tip of the awl broke after impaction during surgery. |
| Initiation date | Nov 22, 2016 |
| Report date | Dec 28, 2016 |
| Termination date | Feb 28, 2017 |
| City | Marietta |
| State | GA |
| Country | United States |
| FEI number | 3007970248 |
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: