| Class 1 Device Recall Mpower | |
Date Initiated by Firm | July 31, 2009 |
Date Posted | October 01, 2009 |
Recall Status1 |
Terminated 3 on December 19, 2011 |
Recall Number | Z-1952-2009 |
Recall Event ID |
52803 |
510(K)Number | K981269 |
Product Classification |
Modular Handpiece - Product Code HRX
|
Product | Mpower PRO6200 Single Trigger Modular Handpiece,
Mpower PRO6202 Battery Two-Trigger Modular Handpiece,
Mpower PRO6300 Battery Oscillating Saw,
Mpower PRO6400 Battery Reciprocating Saw, and
Mpower PRO6450 Battery Sternum Saw.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. |
Code Information |
Mpower PRO6202 Battery Two-Trigger Modular Handpiece, BBB66999 BBB67001 BBB67012 BBB67016 BBB67017 BBB67020 BBB73528 BBB73529 BBB75693 BBB75694 BBB82975 BBB83016 BBB83546 BBB83548 BBB83733 BBB84391 BBB84392 BBB84394 BBB84547 BBB84550 BBB84766 BBB85677 BBB85678 BBB85679 BBB87926 BBB87929 BBB87934 BBB88007 BBB88008 BBB88009 BBB89283 BBB89285 BBB89582 BBB89583 BBB89584 BBB89585 BBB89586 BBB89793 BBB90208 BBB91724 BBB91730 BBB91972 BBB91973 BBB92162 BBB92163 BBB92164 BBB92165 BBB92166 BBB92167 BBB92168 BBB92170 BBB92398 BBB92399 BBB92401 BBB92402 BBB93806 BBB93861 BBB93863 BBB94067 BBB94070 BBB94324 BBB94325 BBB94586 BBB94587 BBB95483 BBB95485 BBB95716 BBB95717 BBB95718 BBB95719 BBB95720 BBB95721 BBB96487 BBB96678 BBB96680 BBB96681 BBB96682 BBB96924 BBB96927 BBB96928 BBB97061 BBB97063 BBB98349 BBB98350 BBB98351 BBB98837 BBB98838 BBB98839 BBB98932 BBB98933 BBC00653 BBC01237 BBC01569 BBC01570 BBC01912 BBC01913 BBC01916 BBC02145 BBC02361 BBC02729 BBC02730 BBC02890 BBC02892 BBC02893 BBC03278 BBC03279 BBC03280 BBC04114 BBC04116 BBC04117 BBC04319 BBC04321 BBC04328 BBC04331 BBC04747 BBC05584 BBC05701 BBC09893 BBC11240 BBC11911 BBC11912 BBC12079 BBC12420 BBC13139 BBC13140 BBC19587 BBC19592 BBC19704 BBC19705 BBC19709 BBC19907 BBC19911 BBC19912 BBC19913 BBC19914 BBC19915 BBC19916 BBC20068 BBC20071 BBC20074 BBC20075 BBC20077 BBC20289 BBC20290 BBC20891 BBC20892 BBC20893 BBC22560 BBC22562 BBC22721 BBC23062 BBC23451 BBC23646 BBC24110 BBC24510 BBC24513 BBC24689 BBC24692 BBC24857 BBC24859 BBC24860 BBC25007 BBC25798 BBC26122 BBC26124 BBC26125 BBC26346 BBC26486 BBC26660 BBC26663 BBC27313 BBC27314 BBC27315 BBC28486 BBC29111 BBC29680 BBC29681 BBC29683 BBC29922 BBC29923 BBC29925 BBC31601 BBC31602 BBC34765 BBC34767 BBC34834 BBC34836 BBC34838 BBC34840 BBC34907 BBC35287 BBC35288 BBC36728 BBC37085 BBC38297 BBC38298 BBC38502 BBC38503 BBC39201 BBC39202 BBC40093 BBC40094 BBC40273 BBC40274 BBC40465 BBC40466 BBC40837 BBC41286 BBC41683 BBC41938 BBC41939 BBC43488 BBC44295 BBC45833 BBC46034 BBC46036 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BBC95705 BBC95706 BBC96288 BBC96289 BBC97537 BBC97776 BBC97777 BBC97778 BBC98338 BBC98644 BBC98772 BBD00314 BBD01637 BBD02033 BBD02246 BBD02247 BBD02456 BBD02457 BBD02458 BBD02702 BBD02703 BBD02949 BBD02951 BBD03157 BBD03831 BBD05356 BBD05357 BBD06931 BBD06932 BBD06933 BBD06934 BBD07375 BBD08218 BBD08556 BBD08558 BBD08845 BBD08846 BBD08848 BBD09126 BBD09128 BBD09728 BBD09931 BBD10217 BBD10218 BBD10219 BBD10443 BBD10444 BBD10445 BBD10446 BBD10644 BBD10645 BBD10646 BBD10647 BBD10882 BBD10884 BBD11571 BBD11774 BBD11776 BBD11777 BBD11987 BBD11989 BBD11990 BBD12150 BBD12151 BBD12152 BBD12153 BBD12154 BBD12403 BBD12404 BBD12405 BBD12586 BBD12587 BBD12588 BBD12589 BBD12590 BBD12591 BBD12868 BBD12869 BBD13029 BBD13499 BBD13500 BBD13661 and BBD13662. |
Recalling Firm/ Manufacturer |
Linvatec Corp. dba ConMed Linvatec 11311 Concept Blvd Largo FL 33773-4908
|
For Additional Information Contact | 727-392-6464 |
Manufacturer Reason for Recall | There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008. |
FDA Determined Cause 2 | Device Design |
Action | Consignees were notified via letter by FedEx delivery or equivalent method. If the product has been further distributed the consignee is requested to notify their consignees. The letter indicated the following risk mitigation actions until affected handpieces are returned to the manufacturer for preventive maintenance: 1) Apply supplied label to the identified handpieces by specific serial number, 2) If self-activation is experienced, discontinue use immediately and return to ConMed Linvtec and 3) Advise/remind the consignee to follow the manufacturers preventive maintenance intervals specified in the instructions for use manuals. Direct questions to ConMed Linvatec at 1-800-237-0169.
Recall Expansion: New amended customer and distributor letters will be sent to those identified customer/distributor accounts. The letter will address the additional units. |
Quantity in Commerce | 1,388 |
Distribution | Worldwide Distribution including United States. |
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.
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510(K) Database | 510(K)s with Product Code = HRX
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