Device recall
Z-0765-2013: Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM…
FDA device recall · Class II · Ormco/Sybronendo
Key facts
| Recall number (Z-number) | Z-0765-2013 |
|---|---|
| Recall event | 64163 |
| Product | Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal. |
| Product code | EKS |
| Recalling firm | Ormco/Sybronendo |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2013 |
| FEI number | 2016150 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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