RecallRadar

FDA Device recall Z-0765-2013

Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525

On 2013-02-13 the FDA classified a Class II recall of Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525 by Ormco Sybronendo, citing the length markings on the Lightspeed LSX files were wrong.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0765-2013
ClassificationClass II
Statusterminated
Initiated2012-12-12
Published2013-02-13
Last updated2026-09-13 11:53 UTC
CompanyOrmco Sybronendo
Distributionn/a

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.

Reason

The length markings on the Lightspeed LSX files were wrong.

Identifiers

code_infoPart # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0765-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.