Drug recall
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral…
FDA recall event 66419 · Class II · Synthes USA HQ, Inc.
Key facts
| Event ID | 66419 |
|---|---|
| Recall numbers | Z-0407-2014 |
| Recalling firm | Synthes USA HQ, Inc. |
| Product type | Devices |
| Products | Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail. |
| Initiation date | Jul 30, 2013 |
| Report date | Dec 4, 2013 |
| Termination date | Sep 10, 2015 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3005180112 |
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: