The Recall Desk
HighFDA (Devices)·Z-1681-2023·Announced 2023-06-14

Surgical anchor inserter recalled for potential tip fracture and bone damage

DePuy Mitek BIOKNOTLESS Rapid anchor inserters may fracture during use, potentially leaving fragments in the patient. If detected during surgery, removal could 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 risk-of-harm medical device with FDA Class II classification where fracture could cause bone damage, but no illnesses or injuries have been reported. The hazard is real but consequences remain theoretical.

Plain-English summary

DePuy Mitek, Inc. is recalling the DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserter (Model 212723) affecting 1,125 units distributed worldwide. The device is used for soft tissue to bone fixation in orthopedic procedures.

The inserter tip can fracture when bending force or bending force with impaction is applied during use. A fragment of the inserter tip may break off and remain inside the patient's body. If the broken fragment is discovered during surgery, removal could cause additional bone damage and prolong operative time.

The affected units were distributed in the United States and internationally, including 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.

Patients and healthcare providers should be aware of this potential risk. If a broken inserter tip is encountered during surgery, extreme care should be taken during removal to minimize additional harm to bone tissue. Healthcare facilities using this device should review affected procedures and contact DePuy Mitek or the FDA for additional guidance.

The recalled product

Product
DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
Manufacturer
DePuy Mitek, Inc., a Johnson & Johnson Co.
Category
Medical Device — Surgical / Orthopedic
Hazard
  • tip-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: 10886705002092 All lot numbers

Distribution

Distributed nationwide across the United States.

Related recalls

Same category