FDA recall Z-1679-2023

Product

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

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

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2023-04-13

Report date

2023-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norwood, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1679-2023