CLASS II ONGOING Device recall · Reported 14 Jun 2023 · FDA Enforcement Report
DePuy Mitek Bioknotless Plus w/ OC-Indicated for use recalled
DePuy Mitek, Inc., a Johnson & Johnson is recalling DePuy Mitek Bioknotless Plus w/ OC-Indicated for use in soft tissue to bone fixation in, distributed nationwide in the US. The recall was initiated on 13 Apr 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1679-2023
- FDA event ID
- 92210
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson, Norwood, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Apr 2023
- FDA classified
- 2 Jun 2023
- Reported
- 14 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 13 Apr 2023 | Recall initiated by company | |
| 2 Jun 2023 | Classified by FDA | +50 days |
| 14 Jun 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
Where it was distributed
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.
Stores named: Walmart
Questions about this recall
Is DePuy Mitek Bioknotless Plus w/ OC-Indicated for use in soft tissue to bone fixation in recalled?
Yes. DePuy Mitek, Inc., a Johnson & Johnson recalled DePuy Mitek Bioknotless Plus w/ OC-Indicated for use in soft tissue to bone fixation in on 13 Apr 2023. The recall is Class II and its status is Ongoing. Recall number Z-1679-2023.
Why was it recalled?
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
Which lots are affected?
UDI-DI: 10886705002122 All lot numbers
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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