Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1679-2023 — DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726

U.S. FDA — Device Enforcement · United States · 2023-04-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1679-2023
Date of alert
2023-04-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DePuy Mitek, Inc., a Johnson & Johnson Co.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10886705002122
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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