Drug recall
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a…
FDA recall event 64989 · Class II · SpineFrontier, Inc.
Key facts
| Event ID | 64989 |
|---|---|
| Recall numbers | Z-1737-2013 |
| Recalling firm | SpineFrontier, Inc. |
| Product type | Devices |
| Products | KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles. |
| Initiation date | Dec 30, 2011 |
| Report date | Jul 24, 2013 |
| Termination date | Jan 8, 2014 |
| City | Beverly |
| State | MA |
| Country | United States |
| FEI number | 3005977257 |
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: