Z-0765-2013 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

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.