Ormco Corporation Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020
Brand
Ormco Corporation
Lot Codes / Batch Numbers
Lot Number 100512025 and 100512020
Products Sold
Lot Number 100512025 and 100512020
Ormco Corporation is recalling Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 10051202 due to Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
Recommended Action
Per FDA guidance
Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026