Z-0765-2013 Class II Terminated
FDA device recall Z-0765-2013 was initiated by Ormco/Sybronendo on December 12, 2012 and is designated Class II. Reason for recall: The length markings on the Lightspeed LSX files were wrong. The recall status is terminated (terminated November 7, 2013). Affected quantity: 740 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2013
- Initiation Date
- December 12, 2012
- Termination Date
- November 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 740 units
Product Description
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 for Recall
The length markings on the Lightspeed LSX files were wrong.
Distribution Pattern
Worldwide Distribution - USA and the country of Canada.
Code Information
Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204.