Recall Z-1678-2023 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
| Date | Jun 2, 2023 (initiated Apr 13, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root 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 |
| Quantity | 540 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040827 | PANALOK LOOP ANCHOR Depuy Mitek, A Johnson & Johnson Company, Apr 30, 2004 |
| K062170 | BIOKNOTLESS AND LUPINE PLUS ANCHORS Depuy Mitek, A Johnson & Johnson Company, Aug 22, 2006 |
| K070925 | MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR Depuy Mitek, A Johnson & Johnson Company, May 2, 2007 |
| K150209 | Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Depuy Mitek, A Johnson and Johnson Company, Oct 6, 2015 |