Class II — DePuy Mitek, Inc., a Johnson & Johnson Co.
| Recalling firm | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
|---|---|
| Registered facility | DePuy Mitek, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Product | DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723 |
| Quantity | 1125 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, Thailand. |
| Initiated | 2023-04-13 |
| Classified | 2023-06-02 |
| Recall number | Z-1681-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DePuy Mitek, Inc., a Johnson & Johnson Co. (Z-1681-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92210/
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