FDAClass IIFebruary 13, 2013

Sybron Endo Lightspeed: LSX Files recall

Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers…

Why was Sybron Endo Lightspeed: LSX Files recalled?

The length markings on the Lightspeed LSX files were wrong.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Ormco/Sybronendo
Quantity
740 units
Distribution
Worldwide Distribution - USA and the country of Canada.
Recall date
February 13, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls