Drug recall
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium…
FDA recall event 67391 · Class II · Synthes, Inc.
Key facts
| Event ID | 67391 |
|---|---|
| Recall numbers | Z-1174-2014 |
| Recalling firm | Synthes, Inc. |
| Product type | Devices |
| Products | Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications. |
| Initiation date | Jan 27, 2014 |
| Report date | Mar 19, 2014 |
| Termination date | Aug 26, 2016 |
| 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: