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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrapower Bur

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  Class 2 Device Recall Ultrapower Bur see related information
Date Initiated by Firm August 09, 2007
Date Posted April 08, 2008
Recall Status1 Terminated 3 on October 01, 2009
Recall Number Z-0711-2008
Recall Event ID 38631
510(K)Number K781979  
Product Classification bur - Product Code GFF
Product ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773
Code Information Lot Numbers: BBD14805 BBD14542 BBD14804 00949613 BBD08721 BBD11468 BBD14258 BBD15139 BBD16978 BBC91085 BBD08725 BBD11465 BBD13560 BBD14265 BBD14533 BBD17117 BBD18411 BBD08940 BBD11470 BBD13564 BBD14680 BBD14711 BBD18412 BBD08939 BBD15429 BBD15591 BBD16681 BBD14944 BBD17632 BBD17835 BBD08961 BBD17399 BBD08935 BBD14264 BBD15416 BBD17423 BBD14935 BBD17832 BBD08942 BBD14261 BBD17633 BBD08448 BBD13158 BBD16029 BBD08943 BBD13565 BBD16122 BBD17627 BBD08389 BBD14260 BBD15401 BBD16652 BBD11471 BBD14266 BBD14658 BBD17631 BBD17836 BBD08443 BBD13567 BBD14747 BBD08445 BBD13569 BBD17896 BBD08959 BBD17626 00950532 BBD08936 BBD13570 BBD08972 BBD15179 BBD08473 BBD13571 BBD14242 BBD15398 BBD17550 BBD08957 BBD08974 BBD16653 BBD08482 BBD17609 BBD08442 BBD15426 BBD16654 BBD08976 BBD14955 BBD08452 BBD09167 BBD14257 BBD16045 BBD08446 BBD15191 BBD16655 BBD08483 BBD15393 BBD16656 BBD08952 BBD11469 BBD16658 BBD17602 BBC89881 BBD08444 BBD16657 BBD17442 BBD08531 BBD15084 BBD17629 BBD14255 BBD14538 BBC92804 BBD15644 BBD16832
Recalling Firm/
Manufacturer		 Linvatec Corp.
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact
727-392-6464
Manufacturer Reason
for Recall		 Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.
FDA Determined
Cause 2		 Packaging process control
Action Conmed Linvatec sent their consignees Urgent New Recall Medical Device Recall Notification letters On August 9, 2007 by UPS overnight delivery. The letter requests the customer return the devices to Linvatec for credit. Domestic Distributors / Sales Representatives were notified by telephone and email.
Quantity in Commerce 1181 units
Distribution Worldwide Distribution.
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 = GFF and Original Applicant = AMERICAN STERILIZER CO.
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