Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020
FDA Recall Z-0203-06 · Posted 2005-11-26
Recalling FirmOrmco Corporation
Recall StatusTerminated
Product CodeDYW
Date Initiated2005-11-03
Date Terminated2006-01-11
Product Quantity1560
Reason for Recall
Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely
shipped domestically prior to receiving FDA 510K market clearance.
Firm Action
Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.