DePuy SIGMA HP MBT Non-Keel Punch Knee Instrument Recalled
DePuy Orthopaedics is recalling 351 SIGMA HP MBT Non-Keel Punch Knee Instruments due to a design defect that may cause surgical complications.
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: The recall involves a medical device defect that may require revision surgery, fitting the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 351 units of the SIGMA HP MBT Non-Keel Punch Knee Instrument. This medical device is designed to be used as an option in stabilizing the tibial trial during trial reduction in knee surgery. The recall covers instruments distributed worldwide, including the United States and numerous international markets.
The recall is due to an increased punch height that creates a 0.063-inch (1.6 mm) gap between the trial and the instrument. This gap may cause a surgeon to select an insert that is too thin. Additionally, the punch may dislodge from the inserter, requiring removal from the joint space and potentially causing surgical delay. If these issues are not noted during surgery, they may result in insert dislocation, spin out, or poor joint mechanics, which may require revision surgery.
Healthcare providers and patients who have used or may use this instrument should contact DePuy Orthopaedics for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 351
Distribution
Distributed nationwide across the United States.
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