Drug recall
Inserter for Titanium Elastic Nails (TEN), orthopedic device
FDA recall event 72133 · Class II · Synthes (USA) Products LLC
Key facts
| Event ID | 72133 |
|---|---|
| Recall numbers | Z-0125-2016 |
| Recalling firm | Synthes (USA) Products LLC |
| Product type | Devices |
| Products | Inserter for Titanium Elastic Nails (TEN), orthopedic device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | potential for mechanical failures such as breakage. |
| Initiation date | Sep 3, 2015 |
| Report date | Oct 21, 2015 |
| Termination date | Oct 4, 2016 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3008812560 |
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: