Date Initiated by Firm |
November 03, 2005 |
Date Posted |
November 26, 2005 |
Recall Status1 |
Terminated 3 on January 11, 2006 |
Recall Number |
Z-0203-06 |
Recall Event ID |
34016 |
510(K)Number |
K052477
|
Product Classification |
Bracket, Plastic, Orthodontic - Product Code DYW
|
Product |
Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020 |
Code Information |
Lot Number 100512025 and 100512020 |
Recalling Firm/ Manufacturer |
Ormco Corporation 1332 S Lone Hill Ave Glendora CA 91740-5339
|
For Additional Information Contact |
Wendy Urtel 949-255-8767
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Other |
Action |
Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05. |
Quantity in Commerce |
1560 |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DYW and Original Applicant = ORMCO CORP.
|