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Class 2 Device Recall APEX Arthroscopy Tubing Set |
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Date Initiated by Firm |
May 30, 2013 |
Date Posted |
July 10, 2013 |
Recall Status1 |
Terminated 3 on September 04, 2013 |
Recall Number |
Z-1680-2013 |
Recall Event ID |
65320 |
510(K)Number |
K954440
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Product Classification |
Arthroscope - Product Code HRX
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Product |
***REF C7120***APEX Arthroscopy Tubing Set.
Intended for use for joint irrigation and dissention during arthroscopic procedures. |
Code Information |
C7120 Lot's #: 1301184, 1301214, 1301254, 1301284, 1301294, 1302014, 1302044, 1302054, 1302064, 1302074, 13020124, 1302134, 1302144, 1302194, 1302204, 1302214, 1302224, 1302254, 1302264, 1303014, 1303054, 1303064, 1303074, 1303114, 1303124, 1303204, 1303214, 1303264, 1303274, 1303284, 1304014, 1304034, 1304054, 1304154, 1304294, 1304304, and 1305014. |
Recalling Firm/ Manufacturer |
Linvatec Corp. dba ConMed Linvatec 11311 Concept Blvd Largo FL 33773-4908
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For Additional Information Contact |
Roger Murphy 727-392-5205
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Manufacturer Reason for Recall |
Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site.
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FDA Determined Cause 2 |
Equipment maintenance |
Action |
ConMed Linvatec sent an "URGENT: Medical Device Recall Notification" letter by FedEx next day delivery or equivalent on 5/30/2013 to all domestic direct consignees. ConMed Linvatec is translating customer notifications letters into the necessary languages and will send International notification letters no later than 6/4/2013. |
Quantity in Commerce |
4,691 Units total of each |
Distribution |
Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan. |
Total Product Life Cycle |
TPLC Device Report
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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 and Original Applicant = LINVATEC CORP.
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