The Recall Desk
HighFDA (Devices)·Z-1678-2023·Announced 2023-06-14

DePuy Mitek BIOKNOTLESS Plus Anchor Inserter Tip May Fracture During Surgery

DePuy Mitek BIOKNOTLESS Plus anchor inserter tips may break and be retained in patients during surgery. Removal of fragments could cause bone damage and prolong surgery 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 Class II recall involves a risk of device failure (inserter tip fracture) with potential for patient harm (bone damage if removal is necessary), but no reported injuries or illnesses are documented. Per the rubric, risk-of-harm products where injury has not yet been reported score High (3).

Plain-English summary

DePuy Mitek BIOKNOTLESS Plus with Panacryl anchor inserter (Model 212725) is being recalled due to a risk that the inserter tip may fracture and break off during use. The tip can fragment when bending force or bending force with impaction is applied during surgery.

If a broken inserter tip is detected during surgery, it may need to be removed from the patient, potentially causing bone damage and extending surgery time. This recall affects 540 units with all lot numbers distributed worldwide, including in the United States, 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 and patients should be aware of this risk and contact DePuy Mitek, Inc. (Johnson & Johnson Company) for guidance on affected product management and potential alternatives for soft tissue to bone fixation procedures.

The recalled product

Product
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
Manufacturer
DePuy Mitek, Inc., a Johnson & Johnson Co.
Category
Medical Device — Surgical / Orthopedic
Hazard
  • fragment-retention
  • bone-damage
  • device-defect

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: 10886705002115 All lot numbers

Distribution

Distributed nationwide across the United States.

Related recalls

Same category