Surgical Anchor Inserter Tip Fragmentation During Patient Procedures
DePuy Mitek's BIOKNOTLESS Plus anchor inserter may fragment during surgical use if bending force is applied. Fragments retained in the patient may require surgical removal, potentially causing bone damage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving risk of intraoperative fragment retention with potential for bone damage, but no reported illnesses or injuries. Qualifies as 'risk-of-harm product where injury has not yet been reported' per the severity rubric.
Plain-English summary
DePuy Mitek BIOKNOTLESS Plus anchor inserter (Model 212724) is being recalled worldwide. This surgical device is used for soft tissue to bone fixation during orthopedic procedures.
The device's inserter tip may fragment if bending force or bending force with impaction is applied during surgery. When the tip breaks, a fragment may remain inside the patient's body.
A broken inserter tip detected during surgery may require surgical removal. This removal could potentially cause bone damage and extend surgery time. No injuries or illnesses have been reported in connection with this recall.
Surgeons and healthcare facilities should be informed of this potential risk when using the BIOKNOTLESS Plus device. If a fragment is detected during or discovered after surgery, evaluation and management should be coordinated with the medical team.
The recalled product
- 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
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- fragmentation
- fragment-retention
- bone-damage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI:10886705002108 All lot numbers
Distribution
Distributed nationwide across the United States.
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