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U.S. Department of Health and Human Services

Class 3 Device Recall Foot Lok Cushion

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 Class 3 Device Recall Foot Lok Cushionsee related information
Date Initiated by FirmMarch 06, 2009
Date PostedAugust 20, 2009
Recall Status1 Terminated 3 on November 05, 2009
Recall NumberZ-1721-2009
Recall Event ID 51317
510(K)NumberK973842 
Product Classification Table, radiographic, stationary top - Product Code IXQ
ProductFoot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.
Code Information Lot NNumbers: M055260, M042340, M024020, M022010 and M006980
Recalling Firm/
Manufacturer		 Med Tec Inc
1401 8th St
PO Box 320
Orange City IA 51041-0320
For Additional Information ContactJenny Jones
800-842-8688 Ext. 309
Manufacturer Reason
for Recall		The silkscreened indexing scale was reversed.
FDA Determined
Cause 2		Error in labeling
ActionMed Tec inc. (CIVCO Medical Solutions, Radiation Oncology) issued a "Recall Notification" notice dated March 6, 2009 via certified mail explaining the reason for recall and providing the customer a choice of returning the product for replacement or not take any action. A response form was enclosed to be returned via FAX to indicate the number of units in their possession and whether or not they are being returned. Telephone calls were initiated April 20, 2009 to nonresponders or for any consignee whose letter was returned as undeliverable. Foreign customers were notified by e-mail or phone beginning March 16, 2009. For further information, contact CIVCO Medical Solutions, Radiation Oncology at 1-800-842-8688.
Quantity in Commerce231 units
DistributionWorldwide Distribution -- Including the United States, Czech Republic, Colombia, Thailand, Morocco, Brazil, the United Kingdom, India, Costa Rica, The Netherlands, Russia, Spain, Israel, Taiwan, Mexico, Turkey, Korea, Australia, Malaysia, Italy and Japan.
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 = IXQ
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