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U.S. Department of Health and Human Services

Class 1 Device Recall VersaCut Morcellator

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 Class 1 Device Recall VersaCut Morcellatorsee related information
Date Initiated by FirmJanuary 02, 2013
Date PostedFebruary 14, 2013
Recall Status1 Terminated 3 on May 20, 2013
Recall NumberZ-0795-2013
Recall Event ID 63858
510(K)NumberK050639 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductThe Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
Code Information Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998.
Recalling Firm/
Manufacturer		 Lumenis Limited
13 Hayetzira St.,Yokneam Ind. Park
Yokneam Israel
Manufacturer Reason
for Recall		Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.
FDA Determined
Cause 2		Labeling design
ActionLumenis sent an Urgent Safety Advisory Notice letter dated January 2, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to re-label the devices with the enclosed labels provided, replace the Operation Manual with the current revised Manual, complete the information requested on the Confirmation Card and return the Confirmation Card using the enclosed pre-paid shipping label by UPS. For question contact VersaCut Morcellator field correction administrator by either Cell: +972-(54)-9599196, Tel: +972-(4)-9599296 or E-mail: VersaCutMorcellator@lumenis.com.
Quantity in Commerce931 units
DistributionWorldwide Distribution - US Nationwide including: CA, WI, NC, FL, PA, IN, NM, NJ, IA, WA, OH, FL, MD, MA, WY, NY, AZ, NH, MN, TN, OK, KY, TX, AK, MI, VT. Internationally: Japan, Nepal, India, UK, South Korea, Netherlands, Germany, Australia, China, Canada, Turkey, Spain, Italy, Egypt, Mexico, Bulgaria, Utd. Arab, Emir., Poland, Kuwait, Hong Kong, Saudi Arabia, Yemen, Qatar, Czech Republic, New Zealand, Malaysia, Portugal, France, Argentina, Singapore, Romania, Chile, Colombia, Switzerland, Bahrain, Brazil, Serbia/Montenero, Taiwan, Israel, Indonesia, Peru, Pakistan, Nepal, Belarus, Latvia, Sri Lanka, Russian Fed, Thailand, Azerbaijan, Belgium, and Denmark.
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 = GCJ
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