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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
Related recalls
Same manufacturer · DePuy Orthopaedics, Inc.
See all →- HighATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
FDA (Devices) · 2024-04-10
- HighAttune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure
FDA (Devices) · 2023-03-29
- HighDePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
- HighOrthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
FDA (Devices) · 2023-03-29
- HighOrthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
Same hazard · surgical complication
See all →- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- HighSurgify Halo Surgical Burr May Break During Spinal Surgery
FDA (Devices) · 2026-07-01
- HighSurgify Halo spinal surgery burr tool potential breakage recall
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burrs recalled for potential breakage
FDA (Devices) · 2026-07-01
Similar recalls
- HighDePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
FDA (Devices) · 2013-12-04
- SevereDePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments
FDA (Devices) · 2013-12-04
- HighDePuy Recalls Knee Instruments Due to Potential Tab Fracture
FDA (Devices) · 2013-12-04
- ModerateDePuy P.F.C. SIGMA Revision Knee Distal Augment Recall
FDA (Devices) · 2018-09-05
- SevereDePuy ATTUNE INTUITION Impaction Handle Recalled for Fracture Risk
FDA (Devices) · 2015-01-21
- HighDePuy Sigma HP Cemented Trochlear Implants Recalled for Elevated Revision Rates
FDA (Devices) · 2018-04-04