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U.S. Department of Health and Human Services

Class 2 Device Recall Sendax MDI

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 Class 2 Device Recall Sendax MDIsee related information
Date Initiated by FirmMay 14, 2010
Date PostedMay 27, 2010
Recall Status1 Terminated 3 on July 14, 2010
Recall NumberZ-1703-2010
Recall Event ID 55744
510(K)NumberK031106 
Product Classification dental implant - Product Code DZE
ProductS1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
Code Information Lot #035D10188
Recalling Firm/
Manufacturer		 3m Imtec Corporation
2401 N Commerce St
Ardmore OK 73401-1311
For Additional Information Contact
800-226-3220
Manufacturer Reason
for Recall		Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.
FDA Determined
Cause 2		Packaging process control
ActionIMTEC notified consignees by phone on May 14, 2010 and by Certified Letter dated May 14, 2010.
Quantity in Commerce189 Implants
DistributionNationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DZE
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