DePuy Mitek recalls BIOKNOTLESS Plus surgical implants with risk of broken inserter tip causing bone damage during surgery. Affected units include model 212725 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 surgical implants that may break during use, potentially causing bone damage and longer surgery times. This risk occurs when applying bending force to the implant's inserter tip.
Applying bending force or impact to the inserter tip during surgery can cause it to break off and remain in the patient. This may require surgical removal, causing additional bone damage and extending procedure time.
Surgical patients and medical professionals using the DePuy Mitek BIOKNOTLESS Plus implants for bone fixation. Those with the specific model number 212725 are most at risk.
Check for model number 212725 on the implant packaging. All units with this model number are affected, regardless of lot numbers.
Inspect the inserter tip for cracks or fragments after surgery; contact your surgeon if you notice damage.
Inform your surgeon if you have the model number 212725 implant and suspect a broken tip during surgery.
No, this recall specifically applies to BIOKNOTLESS Plus implants with model number 212725.
Check with your surgeon if you have the model number 212725 implant and suspect a broken tip during surgery.
Yes, a broken tip may require surgical removal, causing additional bone damage and longer surgery time.
We’ve drafted a message you can send DePuy Mitek to request your refund or repair — edit it as you like.
Subject: Recall Z-1678-2023 — DePuy Mitek DePuy Mitek Hello, I own a DePuy Mitek that is covered by recall Z-1678-2023 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.
