Drug recall
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
FDA recall event 68738 · Class II · Synthes, Inc.
Key facts
| Event ID | 68738 |
|---|---|
| Recall numbers | Z-2265-2014 |
| Recalling firm | Synthes, Inc. |
| Product type | Devices |
| Products | Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the… |
| Initiation date | Jun 30, 2014 |
| Report date | Aug 27, 2014 |
| Termination date | Dec 18, 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: