DePuy Mitek recalls BIOKNOTLESS Rapid W/ OC-Indicated implants due to risk of broken inserter tip causing bone damage during surgery. Affected units include model 212722 with specific UDI-DI 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 Rapid W/ OC-Indicated implants used for bone fixation. The recall is because bending the anchor inserter during use can cause a broken tip to remain in the patient, potentially causing bone damage and longer surgery time.
Bending the anchor inserter during use can cause a fragment of the tip to break off and stay inside the patient. This may require surgical removal, leading to bone damage and longer surgery times.
Surgical patients and medical professionals using DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated implants for bone fixation. Patients who have had surgery with this product are at risk of bone damage if the inserter tip breaks.
Check for model number 212722 and UDI-DI number 10886705002085 on the implant packaging. All lot numbers are affected.
Verify the model number (212722) and UDI-DI (10886705002085) on the implant packaging.
Bending the anchor inserter during use can cause a fragment of the tip to break off and remain in the patient, potentially causing bone damage and longer surgery time.
Check for model number 212722 and UDI-DI number 10886705002085 on the implant packaging. All lot numbers are affected.
The recall does not require immediate discontinuation; however, if you have the product, check for the model and UDI-DI numbers to confirm if it is affected.
We’ve drafted a message you can send DePuy Mitek to request your refund or repair — edit it as you like.
Subject: Recall Z-1680-2023 — DePuy Mitek DePuy Mitek Hello, I own a DePuy Mitek that is covered by recall Z-1680-2023 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.
