FDA Class II Recall: DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use… by DePuy Mitek, Inc., a Johnson & Johnson Co.

Key facts

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724 should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from DePuy Mitek, Inc., a Johnson & Johnson Co.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from DePuy Mitek, Inc., a Johnson & Johnson Co. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to DePuy Mitek, Inc., a Johnson & Johnson Co. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

DePuy Mitek, Inc., a Johnson & Johnson Co.’s FDA history

Argus HQ has recorded 7 total FDA actions tied to DePuy Mitek, Inc., a Johnson & Johnson Co.: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

Is DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use recalled?

Yes. FDA lists a Class II recall by DePuy Mitek, Inc., a Johnson & Johnson Co. for DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724, reported 20230614, with status "Ongoing." FDA recall number: Z-1677-2023.

What is the recall class for DePuy Mitek, Inc., a Johnson & Johnson Co.'s recall?

FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Why was DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use recalled?

FDA's recall record states the reason as: 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

Related enforcement actions

• Recall: DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: COR Disposable Kit, 8 mm. Cartilage Transplant System. →
• Recall: DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. →
• Recall: DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fi… →
• Recall: DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fix… →
• Recall: DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bon… →
• Recall: DePuy Mitek, Inc., a Johnson & Johnson Co. — Class II recall: DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixa… →