Class 2 Device Recall RipCord Syndesmosis Button Kit

• Date Initiated by Firm: December 22, 2022
• Date Posted: February 07, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1101-2023
• Recall Event ID: 91478
• 510(K)Number: K220650
• Product Classification: Washer, bolt nut - Product Code HTN
• Product: RipCord Syndesmosis Button, REF: STA001K
• Code Information: UDI-DI: 00842188123849, Lot: 85305-01
• FEI Number: 3001236812
• Recalling Firm/ Manufacturer: TriMed Inc.; 27533 Avenue Hopkins; Santa Clarita CA 91355-3910
• For Additional Information Contact: Megan Rissler; 661-255-7406
• Manufacturer Reason for Recall: Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
• FDA Determined Cause: Under Investigation by firm
• Action: On 12/22/22, Safety Alert/Advisory Notices were emailed to consignees who were told the following: The updated surgical technique can be found at trimedortho.com/surgical-techniques/ This notice needs to be shared with those who need to be aware within your organization. Acknowledgment and Receipt forms were sent with the notices to be filled out and returned to the firm via the email address below. 1. Deliver the suture passer and pull suture (white/blue) through the soft tissue on the medial side. 2. Maintain gentle tension on the sutures while passing the medial button through the tunnel. Wrapping the pull suture around a finger of one hand and holding the device sutures on the opposite side with the other hand helps maintain gentle, continuous tension as the button is passed and maintains alignment of the medial button with the axis of the tunnel. 3. Gently slide the sutures back and forth to ensure that there are no obstructions and that the sutures are aligned with the bone tunnel. 4. Continue to gently oscillate as the medial button starts to engage the hole and proceed with a swift, consistent pull to deliver the medial button out the medial side. Avoid excessive movement of the fibula relative to the tibia which can misalign the bone tunnels. If excessive resistance is felt, withdraw the button and try again. 5. Once the medial button clears the medial cortex pull back on the device suture to seat the button; cut and remove the pull suture. If you have any questions, please contact quality@trimedortho.com On 2/14/23, recall notices were sent to customers who were asked to do the following: 1) Stop further use of the device and return any unused products to the recalling firm. 2) Provide a copy of this recall notice to the hospital/surgeon/physician that is using the device. 3) Complete and return the response form.
• Quantity in Commerce: 76
• Distribution: US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS
• 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 = HTN