Ormco/Sybronendo: Medical Device Recall in 2013 - (Recall #: Z-0765-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 12, 2012

Date Posted: February 13, 2013

Recall Number: Z-0765-2013

Event ID: 64163

Reason for Recall:

The length markings on the Lightspeed LSX files were wrong.

Status: Terminated

Product Quantity: 740 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated