DePuy Mitek BIOKNOTLESS Rapid implants for bone fixation may break during use, causing retained fragments that require surgery. Affected units include model 212723 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 recalls BIOKNOTLESS Rapid implants that could break during surgery, leaving fragments in the patient. This may require additional surgery and cause bone damage.
Applying bending force to the implant inserter tip can cause it to break during surgery. Broken pieces may remain in the patient, requiring additional surgery to remove and causing bone damage.
Surgical patients using DePuy Mitek BIOKNOTLESS Rapid implants for bone fixation are most at risk. Patients with the specific model number 212723 are affected.
Check for model number 212723 on the implant packaging. All lot numbers are affected, but specific lot numbers aren't listed in the recall notice.
Look for model number 212723 on the implant packaging to confirm if it's affected.
The recall states that applying bending force may cause the tip to break, so it's not safe to use without caution.
No, but patients should check if they have the affected model and follow the recall instructions.
The recall does not specify a remedy, so contact DePuy Mitek directly for guidance.
We’ve drafted a message you can send DePuy Mitek to request your refund or repair — edit it as you like.
Subject: Recall Z-1681-2023 — DePuy Mitek DePuy Mitek Hello, I own a DePuy Mitek that is covered by recall Z-1681-2023 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.
