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U.S. Department of Health and Human Services

Class 2 Device Recall WOM Tube Set for lrrlgatlon

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 Class 2 Device Recall WOM Tube Set for lrrlgatlonsee related information
Date Initiated by FirmMay 24, 2024
Date PostedJuly 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2243-2024
Recall Event ID 94749
510(K)NumberK062380 
Product Classification Arthroscope - Product Code HRX
ProductWOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
Code Information UDI: 04056702003678 Lot Numbers: 4030902, 4030903
Recalling Firm/
Manufacturer		 WOM World Of Medicine AG
Alte Poststr. 11
Ludwigsstadt Germany
For Additional Information ContactSAME
781 749 4656
Manufacturer Reason
for Recall		Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
FDA Determined
Cause 2		Process control
ActionSmith & Nephew Issued Urgent Field Safety Notice (FSN) - MEDICAL DEVICE RECALL WOM reference no.: 2024-0001 via email on 5/24/23. Letter states reason fo recall, health risk and action to take; lnform individuals within your organization who need to be aware of this recall. - Check all stock areas and/or operating room storage to determine if any tube sets with lol numbers from Annex 'l are at your facility, - Dispose of all affected tube sets properly. Confirm this on the customer response form. Return the form to fieldactions@smith-nephew.com. Please send any questions to fieldactions@smith-neDhew.com
Quantity in Commerce1700 units
DistributionUS Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HRX
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