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U.S. Department of Health and Human Services

Class 2 Device Recall MDI Hybrid Implant, OBall Abutment

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  Class 2 Device Recall MDI Hybrid Implant, OBall Abutment see related information
Date Initiated by Firm July 07, 2009
Date Posted September 10, 2009
Recall Status1 Terminated 3 on December 02, 2009
Recall Number Z-1997-2009
Recall Event ID 52614
510(K)Number K081653  
Product Classification Implant, endosseous, root-form - Product Code KKO
Product MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant.

The product is used as a endosseous dental implant.
Code Information Lot numbers for product code MII-OB13: 3503092-43 and 3503093-19. Lot number for product code MII-OB15: 352092-56.
Recalling Firm/
Manufacturer		 IMTEC Corporation
2401 N Commerce St
Ardmore OK 73401-1311
For Additional Information Contact
800-226-3220
Manufacturer Reason
for Recall		 Size printed on product packaging does not match size of enclosed product.
FDA Determined
Cause 2		 Other
Action A notification letter dated July 7, 2009 was issued to customers. The letter described the issue and instructed customers do not use the affected product and call IMTEC, a 3M Company, at 1-800-879-9799, extension 240 for assistance. Customers were further instructed to complete the enclosed Recall Response Fax-Back Form with information on their inventory (whether or not the recalled product is in their stock). The firm's representative will follow-up with customers if no response within three business days of receiving the notification letter.
Quantity in Commerce 605 units
Distribution Worldwide -- US, Azerbaijan, Guatemala, Turkey, and Germany.
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 = KKO and Original Applicant = IMTEC CORP.
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