FDAApril 13, 2023device

DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

depuy mitek inc a johnson johnsondepuydepuy mitek

UPCs

10886705002108

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724 — Recall Details · AllClear