Medical DeviceJun 17, 2020
Ormco/Sybronendo Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq recall — FDA Z-2286-2020
The bracket torque was mislabeled on the packaging.
Class IIFDA: TerminatedOrmco/Sybronendo
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies Ormco/Sybronendo as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.