Class 2 Device Recall

• Date Initiated by Firm: May 04, 2006
• Date Posted: June 02, 2006
• Recall Status: Terminated 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.
• FEI Number: 2210968
• 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: 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