The Recall Desk

Manufacturer

Ormco/Sybronendo

16 recalls in our database name Ormco/Sybronendo as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
0
Most recent
2020-06-17

Of the 16 recalls from Ormco/Sybronendo we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • ModerateFDA (Devices)·Z-2286-2020·2020-06-17

    Ormco Damon Q2 Orthodontic Bracket Recalled for Packaging Labeling Error

    Ormco/Sybronendo is recalling 2,189 units of Damon Q2 Orthodontic Metal Brackets because the bracket torque was mislabeled on the packaging.

    Product
    Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has bee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1257-2020·2020-02-26

    Ormco/Sybronendo Recalls SnapLink Brackets Due to Slide Door Failure

    Ormco/Sybronendo is recalling SnapLink brackets because the lower buccal tube slide doors may not stay closed, potentially causing tooth rotation and treatment delays.

    Product
    SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-1258-2020·2020-02-26

    Ormco SnapLink Brackets Recalled for Slide Door Failure

    Ormco/Sybronendo is recalling SnapLink brackets because lower buccal tube slide doors may not stay closed, potentially causing tooth rotation or treatment delays.

    Product
    SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0413-2018·2018-02-07

    Ormco/Sybronendo Recalls Elements Obturation Units and Buchanan Heat Pluggers

    Ormco/Sybronendo is recalling 25,765 Elements Obturation Units and Buchanan Heat Pluggers because the pluggers may overheat during use.

    Product
    Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2836-2016·2016-09-28

    SybronEndo Recalls Sealapex Xpress Root Canal Resin Due to Labeling Error

    SybronEndo is recalling 179 units of Sealapex Xpress root canal filling resin because the product was labeled with an incorrect expiration date.

    Product
    Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1083-2016·2016-03-16

    Ormco Recalls TF Adaptive Gutta Percha Points Due to Labeling Error

    Ormco is recalling TF Adaptive Gutta Percha Points because the inner label is misidentified as ML3, though the outer package correctly identifies the product as SM3.

    Product
    TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0343-2016·2015-12-09

    Ormco Recalls Copper NiTi Preformed Archwires Due to Incorrect Labeling

    Ormco is recalling Copper NiTi Preformed Archwires because the transformation temperature listed on the label is incorrect.

    Product
    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2014·2014-04-09

    Ormco Recalls Spirit MB Orthodontic Brackets Due to Misplaced ID Dot

    Ormco/Sybronendo is recalling 150 Spirit MB Orthodontic Brackets because a misplaced ID dot may cause incorrect tooth placement.

    Product
    Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1321-2014·2014-04-09

    Ormco Recalls Titanium Orthos Brackets Due to Incorrect Color Marking

    Ormco is recalling 150 units of Titanium Orthos Brackets because the color identification dot was marked on the wrong tie-wing.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2194-2013·2013-09-18

    Ormco Recalls Vector TAS 8mm Orthodontic Screws Due to Manufacturing Defect

    Ormco is voluntarily recalling one lot of Vector TAS 8mm orthodontic screws because some were machined undersized, which may cause the screws to break during use.

    Product
    Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1544-2013·2013-06-26

    SybronEndo Elements Obturation Unit Recalled for Missing Safety Label

    SybronEndo is recalling 3,615 Elements Obturation Units because a required Canadian safety caution label was accidentally omitted from the device and its power cord.

    Product
    SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1545-2013·2013-06-26

    SybronEndo Recalls Dental Power Cords Due to Missing Safety Label

    SybronEndo is recalling 3,615 Elements Obturation Unit power cords because a required Canadian safety label was accidentally omitted from the packaging.

    Product
    SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan The intended use of the Elements Obturation Unit and R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1084-2013·2013-04-17

    Ormco Recalls Bracket Buccal Tubes Due to Packaging Error

    Ormco is voluntarily recalling one lot of Bracket Buccal Tubes because the packaging incorrectly identifies the product offset, which may cause unintended tooth rotation.

    Product
    Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0765-2013·2013-02-13

    Sybron Endo Lightspeed LSX Files Recalled for Incorrect Length Markings

    Ormco/Sybronendo is recalling specific lots of Lightspeed LSX endodontic files because their length markings are incorrect.

    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 ca
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0120-2013·2012-10-31

    Ormco Recalls Damon 3MX Bicuspid Brackets Due to Misidentification

    Ormco/Sybronendo is recalling 148 Damon 3MX Bicuspid Brackets because they were produced with incorrect dark blue ID dots instead of purple, leading to misidentification as maxillary central incisor brackets.

    Product
    The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds
    Category
    Medical Device
    Distribution
    Distributed nationwide