Drug recall
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP…
FDA recall event 65556 · Class II · Synthes (USA) Products LLC
Key facts
| Event ID | 65556 |
|---|---|
| Recall numbers | Z-2057-2013 |
| Recalling firm | Synthes (USA) Products LLC |
| Product type | Devices |
| Products | Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA… |
| Initiation date | May 31, 2013 |
| Report date | Sep 4, 2013 |
| Termination date | Sep 21, 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: