DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue… — Class II medical device recall Z-1681-2023
Ongoing recall by DePuy Mitek, Inc., a Johnson & Johnson Co., reported 2023-06-14, distributed nationwide. IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter ma
| Recall number | Z-1681-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co., Norwood, MA, United States |
| Recall initiated | 2023-04-13 |
| Classified | 2023-06-02 |
| Reported by FDA | 2023-06-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CN, CZ, DE, EG, ES, GB, HK, HU, IE, IN, IT, KR, NL, NZ, SK, TH |
| Quantity | 1,125 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10886705002092 |
| Model numbers | 212723 |
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
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1681-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.