Ormco/Sybronendo: 12 recalls on record

Recalls filed with 1 agency: FDA (12).

First recall on record: October 31, 2012. Most recent: June 17, 2020.

Risk classification: Class II: 11 · Class III: 1

Most recent recalls

DateAgencyProduct
June 17, 2020FDAOrmco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degre…Z-2286-2020
February 26, 2020FDASnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10,…Z-1257-2020
September 28, 2016FDASealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a roo…Z-2836-2016
April 9, 2014FDASpirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. …Z-1330-2014
April 9, 2014FDATitanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot…Z-1321-2014
September 18, 2013FDABrand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS…Z-2194-2013
June 26, 2013FDASybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332…Z-1544-2013
June 26, 2013FDASybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, …Z-1545-2013
April 17, 2013FDABracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal …Z-1084-2013
February 13, 2013FDASybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted…Z-0765-2013
November 14, 2012FDAVector TAS Modular Driver, a manual driver for Vector TAS dental screws.Z-0205-2013
October 31, 2012FDAThe brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part …Z-0120-2013

Questions about this company

How many recalls does Ormco/Sybronendo have?
Recalert has 12 U.S. recalls on record for Ormco/Sybronendo, published between October 31, 2012 and June 17, 2020.
What was the most recent Ormco/Sybronendo recall?
FDA recall Z-2286-2020, published June 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…
Which agencies have handled Ormco/Sybronendo recalls?
Ormco/Sybronendo appears as the recalling firm in recalls from: FDA (12).

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