Bracket, Metal, Orthodontic

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 archw

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.

Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017,

Orthodontic brackets distributed was incorrectly labeled.

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

The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots, which identified them as maxillary central incisor brackets.

Brand name: Orthos CM Bracket, Orthodontic Metal Bracket,

The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of -9. The packaging was labeled with +9 torque; however the brackets contained inside the packaging are actually Orthos CM Brackets with a torque of -9.

Titanium Orthos Bracket

Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.

Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation,

The bracket torque was mislabeled on the packaging.

Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only

Orthodontic Bracket is mislabeled

Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only

Orthodontic Bracket is mislabeled