# FDA recall Z-1679-2023

> **DePuy Mitek, Inc., a Johnson & Johnson Co.** · Class II · device recall initiated 2023-04-13.

## 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

- **Recall number:** Z-1679-2023
- **Recalling firm:** DePuy Mitek, Inc., a Johnson & Johnson Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-13
- **Report date:** 2023-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1679-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1679-2023. Source: US FDA. Licensed CC0.

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