Class 2 Device Recall GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers (CBSG)

• Date Initiated by Firm: July 03, 2024
• Date Posted: August 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2513-2024
• Recall Event ID: 94976
• 510(K)Number: K053200
• Product Classification: Mesh, surgical, polymeric - Product Code FTL
• Product: GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25
• Code Information: Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654
• Recalling Firm/ Manufacturer: W.L. Gore & Associates, Inc.; 301 Airport Rd; Elkton MD 21921-4130
• For Additional Information Contact: MPD Customer Care; 800-528-8763
• Manufacturer Reason for Recall: Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
• FDA Determined Cause: Process control
• Action: On July 1, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the customer/user: 1. Identify and return any unused devices within the scope of this recall for replacement. 2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to FieldActionTeam@wlgore.com within 2 weeks of receipt of this notification. 3. This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). 4. If a listed device has been used, there is no patient follow-up needed and no further actions required other than informing Gore the device was used. Please indicate the used device(s) on the CUSTOMER RESPONSE FORM and return to FieldActionTeam@wlgore.com. In the event that an adverse event occurs: Any adverse event involving the GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers should be reported to W. L. Gore & Associates and the country specific regulatory authorities immediately. To report an event to W. L. Gore & Associates, email: medcomplaints@wlgore.com or contact: USA: 800 528 1866 Ext. 44922 / 928 864 4922, Fax 928 864 4364 Healthcare professionals and consumers may report adverse events or quality problems directly to FDA using the FDA MedWatch Website: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm As a reminder, there is no known additional risk to patients who have been treated with a GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers that is subject to this voluntary recall. We regret any confusion or inconvenience this matter may cause. Please be assured that Gore is committed to ensuring top product quality and customer satisfaction and will be implementing actions as appropriate. Please contact your local Gore Field Sales Associate with any questions regarding this notice, and to coordinate the return and replacement
• Quantity in Commerce: 51 units
• Distribution: US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
• 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 = FTL