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U.S. Department of Health and Human Services

Class 2 Device Recall Ethicon

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  Class 2 Device Recall Ethicon see related information
Date Initiated by Firm March 12, 2019
Create Date April 12, 2019
Recall Status1 Terminated 3 on July 17, 2020
Recall Number Z-1135-2019
Recall Event ID 82420
510(K)Number K061037  
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
Product VICRYL PLUS Sutures:
VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO
VICRYL PLUS SUTURE 18"(45CM) 0 UND
VICRYL PLUS SUTURE 18"(45CM) 0 VIO
VICRYL PLUS SUTURE 18"(45CM) 0 VIO)
VICRYL PLUS SUTURE 18"(45CM) 1 VIO
VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO
VICRYL PLUS SUTURE 27"(70CM) 3-0 VIO
VICRYL PLUS SUTURE 18"(45CM) 2-0 UND
VICRYL PLUS SUTURE 18"(45CM) 1 UND
VICRYL PLUS SUTURE 27"(70CM) 0 UND
VICRYL PLUS SUTURE 27"(70CM) 2-0 UND - Product Usage: Coated VICRYL Suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues
Code Information Product Name/Product Code/Lot Numbers: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VCP713D MJ6586 VICRYL PLUS SUTURE 18"(45CM) 4-0 UND VCP714D MJZ386 VICRYL PLUS SUTURE 18"(45CM) 0 UND VCP724D MJM852 VICRYL PLUS SUTURE 18"(45CM) 0 VIO VCP727D MH2267 VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VCP738D MJ7656 VICRYL PLUS SUTURE 18"(45CM) 0 VIO VCP740D MH2821 VICRYL PLUS SUTURE 18"(45CM) 1 VIO VCP753D MGM113 VICRYL PLUS SUTURE 18"(45CM) 2-0 UND VCP762D MGK480  MK5042  MKK981 VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO VCP773D MGZ815 VICRYL PLUS SUTURE 18"(45CM) 2-0 VIO VCP775D ML2512 VICRYL PLUS SUTURE 27"(70CM) 3-0 VIO VCP784D MJM663 VICRYL PLUS SUTURE 27"(70CM) 2-0 VIO VCP785D MK6998 VICRYL PLUS SUTURE 18"(45CM) 2-0 UND VCP839D ME2930  MK2929  ML7047 VICRYL PLUS SUTURE 18"(45CM) 1 UND VCP841D MG2339 VICRYL PLUS SUTURE 18"(45CM) 3-0 UND VCP864D MK2923 VICRYL PLUS SUTURE 27"(70CM) 0 UND VCPP41D MK6415  ML5418 VICRYL PLUS SUTURE 27"(70CM) 2-0 UND VCPP42D MG6757 
Recalling Firm/
Manufacturer		 Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information Contact SAME
908-218-0707
Manufacturer Reason
for Recall		 VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
FDA Determined
Cause 2		 Packaging process control
Action Ethicon notified primary and secondary US consignees via UPS second day between March 12-15,2019. Receipt of the letter confirmed via UPS tracking. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, Middle East. Latin America and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter describes the problem and action to take:Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). Remove the product subject to this voluntary recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. Do not open foil pouches to confirm contents. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall (removal) letter when communicating. Customers are required to return unused impacted VICRYL Suture, VICRYL Plus Suture, PDS Suture and PDS Plus Suture Products subject to this recall (removal) that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall (removal) by July 31, 2019. Questions regarding this recall (removal) or to report any customer complaints,contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266), Monday through Friday, 7:30 AM to 6:30 PM ET. A Business Reply Form (BRF) asked to be completed and returned.
Quantity in Commerce 550,681 eaches (WW) Total
Distribution Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
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 = NEW and Original Applicant = ETHICON, INC.
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