Device recall: Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attac

FDA enforcement event 67861 · Class II · initiated 25 Mar 2014 · status Terminated · terminated 27 Oct 2014

DeviceVoluntary: Firm initiated1 product recordGlendora, CA

FDA enforcement event 67861 is a device recall by Ormco/Sybronendo of Glendora, CA, initiated 25 Mar 2014 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 27 Oct 2014. 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

"Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets."

Distribution

"US and Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1321-2014	Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.	150 units	Class II	Terminated	9 Apr 2014

Context

91%of 2014 device events are Class II1,176 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
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
17 Jan 2013	SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA	Device	Class II	2

All 14 events for Ormco/Sybronendo

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets."

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: "US and Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 27 Oct 2014. "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.