Drug recall
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic…
FDA recall event 68442 · Class II · Synthes, Inc.
Key facts
| Event ID | 68442 |
|---|---|
| Recall numbers | Z-2087-2014 |
| Recalling firm | Synthes, Inc. |
| Product type | Devices |
| Products | Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no… |
| Initiation date | May 29, 2014 |
| Report date | Jul 30, 2014 |
| Termination date | Aug 18, 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: