FDA Device

Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020

Hazard

Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.

What You Should Do

Remedy

Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.

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Products

Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020
Brand
Ormco Corporation
UPC
Lot Number 100512025 and 100512020

Units Affected

1560

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