Class 2 Device Recall Coated VICRYL (Polyglactin 910) Suture

• Date Initiated by Firm: January 03, 2020
• Date Posted: February 04, 2020
• Recall Status: Terminated on August 13, 2021
• Recall Number: Z-0989-2020
• Recall Event ID: 84639
• 510(K)Number: K022269
• Product Classification: Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
• Product: Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Code Information: lot PGZ908
• FEI Number: 2210968
• Recalling Firm/ Manufacturer: Ethicon, Inc.; Us Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: Ethicon Customer Support Center; 877-384-4266
• Manufacturer Reason for Recall: Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
• FDA Determined Cause: Process control
• Action: The firm notified customers of the recall on January 3, 2020. Customers were informed to immediately cease usage or distribution of the recalled lot. All unused product subject to the recall is to be returned to the firm. If any recalled product was forwarded to another facility, contact that facility to arrange return. Customers were also asked to complete and return the included business reply form to the recalling firm even if they did not have product subject to this recall. In addition, customers are to keep the recall notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. If you require any assistance with returning product, please contact Stericycle at 877-550-0701 and reference Event # 3453. Health care practitioners who have treated patients using this product should follow those patients post-operatively in the usual manner with no additional action required. If you have additional questions regarding this recall or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.
• Quantity in Commerce: 23688 units
• Distribution: Domestic distribution nationwide. US and Puerto Rico only.
• 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