Drug recall
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in…
FDA recall event 69753 · Class II · Synthes (USA) Products LLC
Key facts
| Event ID | 69753 |
|---|---|
| Recall numbers | Z-0931-2015 |
| Recalling firm | Synthes (USA) Products LLC |
| Product type | Devices |
| Products | Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause… |
| Initiation date | Nov 6, 2014 |
| Report date | Jan 14, 2015 |
| Termination date | Aug 17, 2015 |
| 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: