Class 2 Device Recall PERMAHAND" Silk Suture

• Date Initiated by Firm: September 08, 2026
• Date Posted: October 14, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0153-2027
• Recall Event ID: 99754
• 510(K)Number: K946173
• Product Classification: Suture, nonabsorbable, steel, monofilament and multifilament, sterile - Product Code GAQ
• Product: PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
• Code Information: UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026
• FEI Number: 2648650
• Recalling Firm/ Manufacturer: Ethicon, LLC; Highway 183 Km 8.3; San Lorenzo PR 00754
• For Additional Information Contact: 787-783-7070
• Manufacturer Reason for Recall: Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
• FDA Determined Cause: Process control
• Action: On 9/8/2026, recall notices were mailed to customers who were asked to do the following: 1) Quarantine affected products. Maintain a copy of this notice with the quarantined product and keep a copy for your records. 2) Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return and forward them this recall notice. 3) Complete and return the Business Reply Form via email to ethicon4483@sedgwick.com 4) Return affected product using the shipping label provided. In addition distributors were told the following: Based on your reported sales data, Ethicon will send notices directly to customers about the product subject to this recall. This notice will include instructions on returning the product for credit reimbursement. Distribute this notice within your organization and to any non-customer organization that received affected product from your facility. If you have additional questions regarding this communication or want to report any product complaints, please contact the firm's Resource Department at 1-877-384-4266.
• Quantity in Commerce: 1764
• Distribution: Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GAQ