Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Pa...
FDA Recall #Z-0765-2013 — Class II — December 12, 2012
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.
Recalling Firm
Ormco/Sybronendo — Glendora, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
740 units
Distribution
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated