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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 04, 2006
Date Posted June 02, 2006
Recall Status1 Terminated 3 on December 17, 2007
Recall Number Z-1087-06
Recall Event ID 35336
510(K)Number K022269  
Product Classification Suture, Absorbable, Synthetic, Polyglycolic Acid - Product Code GAM
Product Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.
Code Information Product Codes/Product Lot Numbers-Expiration Dates: J774D/SB2371-01/2008; JB725/SB2416-01/2008; J864D/SB2426-01/2008.
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
(PO Box 151)
Somerville NJ 08876
For Additional Information Contact Cindy L. Crosby
908-218-3365
Manufacturer Reason
for Recall		 Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.
FDA Determined
Cause 2		 Other
Action The firm sent out recall notification on 5/4/2006. The US consignees were sent a letter via return receipt.
Quantity in Commerce 1157 dozens
Distribution Nationwide, Japan, Canada, and Taiwan.
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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