Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. Due to IFU Warning: Applying bending force and/or bending force...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Mitek, Inc., a Johnson & Johnson Co. directly.
Affected Products
DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
Quantity: 3328 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek, Inc., a Johnson & Johnson Co. has 51 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report