DePuy Mitek recalls BIOKNOTLESS Plus implants with a risk of broken inserter tips causing bone damage during surgery. Affected units include model 212726 with specific lot numbers.
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
DePuy Mitek is recalling BIOKNOTLESS Plus implants used for soft tissue to bone fixation. The recall is due to a risk that the anchor inserter tip could break during use, potentially causing bone damage and longer surgery times.
Applying bending force or impact to the anchor inserter tip may cause it to break during surgery. Broken fragments could remain in the patient, requiring removal and causing additional bone damage and extended surgery time.
Patients undergoing surgery with the recalled implant are affected. Surgeons and medical staff using the device during procedures are at highest risk.
The product is labeled as DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for soft tissue to bone fixation. Model number 212726 and specific lot numbers are included in the recall.
Review the model number (212726) and lot numbers on the device to confirm if it is affected.
The recall indicates a risk of broken inserter tips during surgery, so it is not safe to use without checking the recall status.
Check the model number and lot numbers on the device to see if it is affected by the recall. Contact DePuy Mitek for further instructions.
The recall does not mention a repair option; affected units may need to be replaced.
We’ve drafted a message you can send DePuy Mitek to request your refund or repair — edit it as you like.
Subject: Recall Z-1679-2023 — DePuy Mitek DePuy Mitek Hello, I own a DePuy Mitek that is covered by recall Z-1679-2023 from DePuy Mitek. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
