Device 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.
Z-0765-2013
Product summary
- Firm
- Ormco/Sybronendo
- Event
- Event 64163
- Status
- Terminated
- Classification
- Class II
- Quantity
- 740 units
- Official record key
device-enforcement:Z-0765-2013
Official wording
Reason: The length markings on the Lightspeed LSX files were wrong.
Code information: Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204.
Distribution pattern: Worldwide Distribution - USA and the country of Canada.
Derived failure modes
-
Unknown
The length markings on the Lightspeed LSX files were wrong.