DePuy Mitek surgical anchor inserter may fracture during use
DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.
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: This is a Class II medical device recall involving risk of retained foreign material in patients. While no injuries have been reported, the hazard involves potential bone damage and extended surgery time during fragment removal, meeting the threshold for High severity.
Plain-English summary
DePuy Mitek BIOKNOTLESS Rapid W/ OC surgical anchor inserters (Model 212722) are subject to a recall due to a risk of instrument fracture during use. Applying bending force or bending force with impaction to the anchor inserter may cause the inserter tip to break off and remain in the patient.
The device has been distributed worldwide, including throughout the US and internationally. Approximately 3,328 units are affected across all lot numbers.
If a broken inserter tip is detected during surgery, removal may be necessary. This removal procedure can cause bone damage and extend surgical time. Patients and healthcare providers should be aware of this potential complication.
Patients who have undergone or are scheduled for procedures using this device should consult with their healthcare provider about the recall.
The recalled product
- Product
- DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- material-fracture
- retained-fragment
- 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: 10886705002085 All lot numbers
Distribution
Distributed nationwide across the United States.
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