Class 2 Device Recall PERMAHAND Silk Suture

• Date Initiated by Firm: December 18, 2018
• Create Date: January 16, 2019
• Recall Status: Terminated on May 29, 2020
• Recall Number: Z-0747-2019
• Recall Event ID: 81820
• 510(K)Number: K946173
• Product Classification: Suture, nonabsorbable, silk - Product Code GAP
• Product: PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
• Code Information: Product Lot MEH906
• FEI Number: 2210968
• Recalling Firm/ Manufacturer: Ethicon, Inc.; Us Highway 22 West; Somerville NJ 08876
• Manufacturer Reason for Recall: The sutures inside the packaging are not the same size or type as indicated on the label.
• FDA Determined Cause: Packaging process control
• Action: Ethicon sent an Urgent Medical Device Recall notification letters to customers on 12/18/18. The letter identified the affected product, problem and actions to be taken. For questions contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266).
• Quantity in Commerce: 840
• Distribution: The products were distributed to the following US states: AR, CA, FL, GA, KS, LA, MO, MS, ND, NE, NJ, NY, OH, PA, and WI.
• 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 = GAP