Device recall: Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; L

FDA enforcement event 64163 · Class II · initiated 12 Dec 2012 · status Terminated · terminated 7 Nov 2013

DeviceVoluntary: Firm initiated1 product recordGlendora, CA

FDA enforcement event 64163 is a device recall by Ormco/Sybronendo of Glendora, CA, initiated 12 Dec 2012 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 7 Nov 2013. Initiation: voluntary: firm initiated. Ormco/Sybronendo has 14 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Ormco/Sybronendo, Glendora, CA.

Reason for recall

"The length markings on the Lightspeed LSX files were wrong."

Distribution

"Worldwide Distribution - USA and the country of Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0765-2013	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.	740 units	Class II	Terminated	13 Feb 2013

Context

88%of 2012 device events are Class II823 events that year

1product record in this eventfirm median: 1

14events on this register for the firm

Other enforcement events for Ormco/Sybronendo

Initiated	Product (first record)	Type	Class	Records
17 Jan 2020	SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx On	Device	Class II	2
14 Jan 2020	Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco C	Device	Class II	1
27 Dec 2017	Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. I	Device	Class II	1
31 Aug 2016	Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xp	Device	Class II	1
8 Feb 2016	TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal	Device	Class II	1
4 Nov 2015	Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth move	Device	Class II	1
25 Mar 2014	Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic br	Device	Class II	1
25 Mar 2014	Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attac	Device	Class II	1
12 Jul 2013	Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a f	Device	Class II	1
8 Mar 2013	Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodont	Device	Class II	1

All 14 events for Ormco/Sybronendo

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The length markings on the Lightspeed LSX files were wrong."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - USA and the country of Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 7 Nov 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.