Drug recall
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary…
FDA recall event 71834 · Class II · Synthes (USA) Products LLC
Key facts
| Event ID | 71834 |
|---|---|
| Recall numbers | Z-2475-2015 |
| Recalling firm | Synthes (USA) Products LLC |
| Product type | Devices |
| Products | Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The end cap may loosen and detach making the instrument non-functional. No injuries reported. |
| Initiation date | Jul 22, 2015 |
| Report date | Sep 2, 2015 |
| Termination date | Aug 18, 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: