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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-1134-2019
Recall Event ID 82420
510(K)Number K022715  
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
Product VICRYL Sutures
VICRYL SUTURE 18"(45CM) 0 VIO
VICRYL SUTURE 18"(45CM) 4-0 UND
VICRYL SUTURE 18"(45CM) 2-0 VIO
VICRYL SUTURE 18"(45CM) 0 VIO
VICRYL SUTURE 18"(45CM) 2-0 VIO
VICRYL CT VIO 8X18IN 0 S/A CT-1 CR
VICRYL SUTURE 18"(45CM) 1 VIO
VCL CT UD 8X18IN 2-0 S/A CP-2 CR
VCL CT VIO 8X18IN 3-0 S/A SH-1 CR
VICRYL CT VIO 8X18IN 2-0 S/A SH CR
VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR
VICRYL CT UD 8X18IN 0 S/A CT-1 CR
VCL CT UD 8X18IN 1 S/A CT-1 CR 9
VICRYL SUTURE 18"(45CM) 0 UND
VICRYL CT VIO 8X27IN 0 S/A CT-1 CR
VICRYL SUTURE 27"(70CM) 1 UND
VICRYL CT UD 8X27IN 0 S/A CT-1 CR
VICRYL SUTURE 27"(70CM) 0 VIO
Code Information Product Name/Product Code/Lot Numbers: VICRYL SUTURE 18"(45CM) 0 VIO D6043 MKM683, ML5314 VICRYL SUTURE 18"(45CM) 2-0 UND D6226 MJM912 VICRYL SUTURE 18"(45CM) 0 VIO J701D MJ6796 VICRYL SUTURE 18"(45CM) 3-0 VIO J713D MGK411 VICRYL SUTURE 18"(45CM) 4-0 UND J714D ME5059  MKM907 VICRYL SUTURE 18"(45CM) 2-0 VIO J726D ME5454 VICRYL SUTURE 18"(45CM) 0 VIO J727D MHZ777 VICRYL SUTURE 18"(45CM) 2-0 VIO J739D MGZ324  MHM399 VICRYL CT VIO 8X18IN 0 S/A CT-1 CR 740D ME6539  MJM523 VICRYL SUTURE 18"(45CM) 1 VIO J741D MGZ624  MJ5193 VCL CT UD 8X18IN 2-0 S/A CP-2 CR J762D MJZ094  MLZ026 VCL CT VIO 8X18IN 3-0 S/A SH-1 CR J772D MHZ196 VICRYL CT VIO 8X18IN 2-0 S/A SH CR J775D MLZ864 VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR J839D MG2349  MG2593  MG2666  MG7585  MK2820 VICRYL CT UD 8X18IN 0 S/A CT-1 CR J840D MEK770  MGK812  MJK773  MM6633 VCL CT UD 8X18IN 1 S/A CT-1 CR J841D MEK194  MGK749  MMM998 VCL CT UD 8X18IN 3-0 S/A SH CR J864D MEK524  MGZ556  MHZ379  MHZ475  MJK262 VICRYL SUTURE 18"(45CM) 0 UND JB840 MEK959  MGM275  MGM643  MM6544 VICRYL CT VIO 8X27IN 0 S/A CT-1 CR JJ31G MJK828 VICRYL SUTURE 27"(70CM) 1 UND JJ40G ME6809 VICRYL CT UD 8X27IN 0 S/A CT-1 CR JJ41G ME5281  MGZ466  MGZ563  MHK212 VICRYL SUTURE 27"(70CM) 0 VIO JJ81G MKK878 
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 = GAM and Original Applicant = ETHICON, INC.
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