Drug recall
Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a…
FDA recall event 75255 · Class II · Hand Biomechanics Lab Inc
Key facts
| Event ID | 75255 |
|---|---|
| Recall numbers | Z-0136-2017 |
| Recalling firm | Hand Biomechanics Lab Inc |
| Product type | Devices |
| Products | Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A number of Agee WristJack¿ Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the… |
| Initiation date | Sep 14, 2016 |
| Report date | Oct 26, 2016 |
| Termination date | Nov 15, 2016 |
| City | Sacramento |
| State | CA |
| Country | United States |
| FEI number | 2919128 |
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: