Z-0765-2013Class II

Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers...

Name: Z-0765-2013 Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers...
Creator: Ormco/Sybronendo
Published: 2012-12-12
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2012-12-12 / Terminated / root cause: manufacturing process

FDA source

Ormco/Sybronendo began a recall of 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... on 2012-12-12. FDA classified it as Class II and gives the reason as "The length markings on the Lightspeed LSX files were wrong". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0765-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-12
Posted: 2013-02-01
Terminated: 2013-11-07
Recalling firm: Ormco/Sybronendo
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.
Product code: EKS File, Pulp Canal, Endodontic
Reason for recall: The length markings on the Lightspeed LSX files were wrong.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Sybron Endo sent a Urgent: Medical Device Recall letter dated December 21, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has come to our attention that the length rings laser-etched on several lots of the Lightspeed LSX Files are inaccurate. We are asking for the product to be returned since use of the file could be a safety risk due to misadjustment of the file length. Please contact SybronEndo Customer Care at 1-800-346-3636 directly to handle the arrangements of a quick return and replacement.
Quantity in commerce: 740 units
Distribution: Worldwide Distribution - USA and the country of Canada.
Product codes and lots: Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0765-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0765-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-01

Product code EKS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)