DePuy Mitek recalls BIOKNOTLESS Plus surgical anchors with a risk of broken inserter tips causing bone damage during surgery. Affected units include specific model and 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 surgical anchors that may break during use, potentially causing bone damage. This risk occurs when applying bending force to the anchor inserter tip.
Applying bending force or impact to the anchor inserter tip can cause it to break during surgery. Broken pieces may remain in the patient, requiring removal and causing bone damage or longer surgery times.
Surgical patients and medical professionals using DePuy Mitek BIOKNOTLESS Plus anchors for soft tissue to bone fixation. Those with the specific model number 212724 are most at risk.
Check for model number 212724 on the product. All lot numbers are affected. This product is used for soft tissue to bone fixation in surgery.
Look for model number 212724 on the device.
Reach out to DePuy Mitek for guidance on next steps.
The product may break during use, causing bone damage. Do not use if you have the model number 212724.
Check the model number and contact DePuy Mitek for instructions.
Yes, broken pieces may remain in the patient, requiring removal and causing bone damage or longer surgery times.
We’ve drafted a message you can send DePuy Mitek to request your refund or repair — edit it as you like.
Subject: Recall Z-1677-2023 — DePuy Mitek DePuy Mitek Hello, I own a DePuy Mitek that is covered by recall Z-1677-2023 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.
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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.
