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U.S. Department of Health and Human Services

Class 2 Device Recall LIGAMAX

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  Class 2 Device Recall LIGAMAX see related information
Date Initiated by Firm November 07, 2019
Create Date December 06, 2019
Recall Status1 Terminated 3 on April 23, 2021
Recall Number Z-0656-2020
Recall Event ID 84280
510(K)Number K110699  
Product Classification Clip, implantable - Product Code FZP
Product Ligamax 5 mm Endoscopic Multiple Clip Applier
Code Information Product Code: 11EL5ML Lot Numbers: T93X4R, T93X9D, T93Y2Z, T93Y70, T93Y96, T93Z52, T93Z76, T9401C, T9408F, T94118, T9416M, T9422K, T9426Z, T94402, T94536, T94567, T9461M, T94667, T94721, T94758, T94807, T9484Y, T9487J, T9491A T94A9K, T94C2Z, T94C8N, T94D2N, T94E66, T94F3C, T94F7F, T94G99 T94H1N, T94H78 
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information Contact Stephanie Matthews
513-337-3521
Manufacturer Reason
for Recall		 A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
FDA Determined
Cause 2		 Under Investigation by firm
Action On November 7, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT: MEDICAL DEVICE RECALL (REMOVAL) LIGAMAX  5mm Endoscopic Multiple Clip Applier Product Codes: EL5ML (Multiple Lot Numbers) Dear Valued Customer Ethicon has initiated a voluntary medical device recall (removal) of specific lots of LIGAMAX  5mm Endoscopic Multiple Clip Applier. Ethicon identified that a potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility. In the event that the sterility barrier has been breached, there is a chance that a pathogen may be introduced and if unrecognized or untreated may cause life threatening infection. As the population at risk is most likely to receive prophylactic antibiotics the probability of harm is extremely rare. We have identified the root cause and have implemented corrective actions to address the issue and prevent reoccurrence. As of the date of this communication, no adverse events or complaints have been reported for this issue. Our records indicate that you may have ordered or received product subject to this recall. PLEASE DISTRIBUTE THIS INFORMATION TO ALL STAFF WITHIN YOUR FACILITY WHO USE LIGAMAX  5mm ENDOSCOPIC MULTIPLE CLIP APPLIER. The dates of distribution for affected products were from July 31, 2019 thru October 4, 2019. EFFECTIVE IMMEDIATELY  DO NOT USE OR DISTRIBUTE THE FOLLOWING PRODUCT CODE/ LOT: Product Name: LIGAMAX Product Code: EL5ML Product Lots: T93X4R, T93X9D, T93Y2Z, T93Y70, T93Y96, T93Z52, T93Z76, T9401C, T9408F T94118, T9416M, T9422K, T9426Z, T94402, T94536, T94567, T9461M, T94667, T94721, T94758, T94807, T9484Y, T9487J, T9491A, T94A9K, T94C2Z, T94C8N, T94D2N, T94E66, T94F3C, T94F7F, T94G99, T94H1N T94H78 Description/Size: 5mm Endoscopic Multiple Clip Applier Note: This recall is specific to lots described. Health care practitioners who have treated pat
Quantity in Commerce 48,428
Distribution US: Nationwide International: ARGENTINA ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHINA COLOMBIA DENMARK ESTONIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS NEW CALEDONIA NEW ZEALAND PANAMA PHILIPPINES PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SLOVENIA SWEDEN SWITZERLAND TAIWAN UK
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 = FZP and Original Applicant = ETHICON ENDO-SUGERY, LLC
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