FDA Medical Device Recalls (openFDA)
DePuy Mitek, Inc., a Johnson & Johnson Co.: DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
- Recall number
- Z-1681-2023
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Product
- DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
- Status
- Open, Classified
- Initiated
- 2023-04-13
- Posted
- 2023-06-02
- Terminated
- not on file
- Reason
- 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
- Root cause
- Use error
- Action
- DePuy Mitek issued Urgent Medical Device Correction (Notification) Letter on 4/13/23 via First Class Mail to US consignees. Internal and sales/distributors notified via email. International affiliates will be notified via email and will be initiated per local regulations. Letter states reason for recall, health risk and action to take: 1. Product is NOT being removed from the field and does not need to be returned. 2. Familiarize yourself with the content 2. Familiarize yourself with the content of this letter. 3. Review, complete all fields, sign, and return the attached business response form (BRF) on the last page of this letter to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this notification. IMPORTANT: Complete the BRF even if you do not have any of the subject product in your current inventory. 4. Forward this notice to any personnel in your facility who need to be informed. 5. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.
- Quantity
- 1125 units
- 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.
- Lot, serial or model codes
- UDI-DI: 10886705002092 All lot numbers
- 510(k) numbers
- ["K040827","K062170","K070925","K150209"]
- PMA numbers
- not on file
- Product code
- MAI
- Firm FEI
- 1221934
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28