Device recall
Z-1941-2013: 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System…
FDA device recall · Class II · OrthoPediatrics Corp
Key facts
| Recall number (Z-number) | Z-1941-2013 |
|---|---|
| Recall event | 65828 |
| Product | 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw. |
| Product code | HWC |
| Recalling firm | OrthoPediatrics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 26, 2013 |
| 510(k) numbers | K083286 |
| FEI number | 3006460162 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database