Class 2 Device Recall Bioknotless Anchor (Arthroscopic)

• Date Initiated by Firm: April 13, 2023
• Date Posted: June 02, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1679-2023
• Recall Event ID: 92210
• 510(K)Number: K150209 K062170 K070925 K040827
• Product Classification: Fastener, fixation, biodegradable, soft tissue - Product Code MAI
• Product: DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization ; Model Number: 212726
• Code Information: UDI-DI: 10886705002122 All lot numbers
• Recalling Firm/ Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.; 249 Vanderbilt Ave; Norwood MA 02062-5033
• For Additional Information Contact: SAME; 508-880-8100
• Manufacturer Reason for Recall: IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
• FDA Determined Cause: Use error
• Action: DePuy Mitek issued Urgent Medical Device Correction (Notification) Letter on 4/13/23 via First Class Mail to US consignees. Internal and sales/distributors notified via email. International affiliates will be notified via email and will be initiated per local regulations. Letter states reason for recall, health risk and action to take: 1. Product is NOT being removed from the field and does not need to be returned. 2. Familiarize yourself with the content 2. Familiarize yourself with the content of this letter. 3. Review, complete all fields, sign, and return the attached business response form (BRF) on the last page of this letter to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this notification. IMPORTANT: Complete the BRF even if you do not have any of the subject product in your current inventory. 4. Forward this notice to any personnel in your facility who need to be informed. 5. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.
• Quantity in Commerce: 2372 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, Thailand.
• 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 = MAI and Original Applicant = DEPUY MITEK, A JOHNSON & JOHNSON COMPANY; 510(K)s with Product Code = MAI and Original Applicant = Depuy Mitek, a Johnson and Johnson Company