PlainRecalls

Ormco/Sybronendo

Compiled from official public sources by the publisher.

16 recalls on record · Latest: Jun 17, 2020

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Agency notice ledger

Federal filing book Ormco/Sybronendo LIGHT-BOOK · SINGLE-AGENCY

#989 of 14,151 · 16 notices · 0.015% archive

  • BOOK 16 notices
  • RANK #989 of 14,151
  • SHARE 0.015% archive
  • AGENCY FDA Devices (16)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jun 17, 2020
  • PHOTO Acella Pharmaceutical…

Nearest notice-volume peer: Acella Pharmaceuticals, LLC (0 notice gap)

Ormco/Sybronendo accounts for about 0.015% of the 104,423-notice archive on 16 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Ormco/Sybronendo sits among 14,151 recalling firms

Ormco/Sybronendo ranks 989th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Ormco/Sybronendo vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

16 989th of 14151 higher than 13,145 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Ormco/Sybronendo in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Ormco/Sybronendo holds about 0.015% of archive notices alongside 16 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jun 17, 2020

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 been completed.
FDA Devices Moderate Feb 26, 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 Only
FDA Devices Moderate Feb 26, 2020

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
FDA Devices Moderate Feb 7, 2018

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 cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.
FDA Devices Moderate Sep 28, 2016

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.
FDA Devices Moderate Mar 16, 2016

TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
FDA Devices Moderate Dec 9, 2015

Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
FDA Devices Moderate Apr 9, 2014

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.
FDA Devices Moderate Apr 9, 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.
FDA Devices Moderate Sep 18, 2013

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 orthodontic treatment has been completed. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices.
FDA Devices Moderate Jun 26, 2013

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 Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha

FDA Devices Moderate Jun 26, 2013

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 Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic ro
FDA Devices Moderate Apr 17, 2013

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
FDA Devices Moderate Feb 13, 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.
FDA Devices Moderate Nov 14, 2012

Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
FDA Devices Low Oct 31, 2012

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 an archwire during orthodontic treatment.

Ormco/Sybronendo holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name Ormco/Sybronendo? ▼
PlainRecalls indexes 16 distinct federal recall events naming Ormco/Sybronendo, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Ormco/Sybronendo sit among other recalling firms? ▼
Ormco/Sybronendo ranks #989 of 14,151 by distinct recall-event count among 14,151 firms in this archive (93rd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Ormco/Sybronendo's notices? ▼
FDA Devices accounts for 16 of this firm's 16 indexed notices.
What product category dominates Ormco/Sybronendo's filing book? ▼
Filings for Ormco/Sybronendo span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Ormco/Sybronendo: 16 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Ormco/Sybronendo; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026