Z-1678-2023 Class II Ongoing
FDA device recall Z-1678-2023 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Apr 13, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 540 units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 14, 2023
- Initiation Date
- Apr 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 540 units
Product description
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
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 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.
Code information
UDI-DI: 10886705002115 All lot numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1678-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026