FDA Device recall Z-0765-2013
Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525
- FDA Device
- Class II
- terminated
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class II recall of Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525 by Ormco Sybronendo, citing the length markings on the Lightspeed LSX files were wrong.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0765-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-12 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ormco Sybronendo |
| Distribution | n/a |
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.
Reason
The length markings on the Lightspeed LSX files were wrong.
Identifiers
| code_info | Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0765-2013%22
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