Drug recall
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large); (S) intended to…
FDA recall event 71876 · Class II · Synthes (USA) Products LLC
Key facts
| Event ID | 71876 |
|---|---|
| Recall numbers | Z-2451-2015 |
| Recalling firm | Synthes (USA) Products LLC |
| Product type | Devices |
| Products | Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System… |
| Initiation date | Jul 29, 2015 |
| Report date | Sep 2, 2015 |
| Termination date | Sep 27, 2016 |
| 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: