Z-1677-2023Class II
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association...
DePuy Mitek, Inc. / initiated 2023-04-13 / Open, Classified / root cause: labeling and UDI
DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1677-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- DePuy Mitek, Inc.
- Product
- DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
- Product code
- MAI Fastener, Fixation, Biodegradable, Soft Tissue
- 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
- Root cause tag
- labeling and UDI
- FDA 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 [email protected] 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 in commerce
- 805 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.
- Product codes and lots
- UDI-DI:10886705002108 All lot numbers
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1677-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1678-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1679-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1680-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1681-2023 | Class II | Ongoing | Voluntary: Firm initiated |
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