The Recall Desk
HighFDA (Devices)·Z-1679-2023·Announced 2023-06-14

DePuy Mitek surgical anchor inserter tip may fragment and be retained

DePuy Mitek BIOKNOTLESS Plus surgical anchor inserters may have tips that break off during use and remain in the patient. This could require surgical removal that may cause 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: This is a Class II medical device recall involving risk of device fragment retention with potential for bone damage during removal. No reported cases of injury or hospitalization are mentioned in the source text, making this a risk-of-harm scenario without documented incidents.

Plain-English summary

DePuy Mitek, Inc., a Johnson & Johnson Company, is recalling 2,372 units of the DePuy Mitek BIOKNOTLESS Plus surgical anchor inserter (Model 212726, UDI-DI: 10886705002122) worldwide. This device is used in soft tissue to bone fixation procedures in association with adequate postoperative immobilization.

The device carries an instruction for use 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. If a broken inserter tip is detected during surgery, it may require removal, which could potentially cause bone damage and longer surgery time.

The recalled devices have been distributed worldwide, including throughout the United States and internationally to Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, and Thailand. Healthcare providers who have received these devices should discontinue use and contact DePuy Mitek for further instructions.

The recalled product

Product
DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
Manufacturer
DePuy Mitek, Inc., a Johnson & Johnson Co.
Category
Medical Device — Surgical Anchors
Hazard
  • fragmentation
  • 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: 10886705002122 All lot numbers

Distribution

Distributed nationwide across the United States.

Related recalls

Same category