DePuy Mitek, Inc., a Johnson & Johnson Co.: Medical Device Recall in 2023 - (Recall #: Z-1679-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 13, 2023

Date Posted: June 14, 2023

Recall Number: Z-1679-2023

Event ID: 92210

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

Status: Ongoing

Product Quantity: 2372 units

Code Information:

UDI-DI: 10886705002122 All lot numbers

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated