DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. The hazard involves a component fracturing and being left inside a patient, which constitutes a significant injury risk.
Plain-English summary
DePuy Orthopaedics, Inc. is issuing a voluntary device correction for the SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH CEMENTED Size 2-3. This knee instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray during total knee arthroplasty.
The recall is being issued because of the potential for tabs on the connection end of the instrument to fracture and be left in the patient. The agency has classified this recall as Class II.
A total of 29,235 units were distributed worldwide from 2008 through November 2013. Distribution included the United States and numerous international locations. Healthcare providers should stop using the affected instruments and contact DePuy Orthopaedics for further instructions.
The recalled product
- Product
- SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
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)
- Item #950502011
Distribution
Part of a larger recall action
This product is one of 12 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →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 · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- HighDePuy SIGMA HP MBT Non-Keel Punch Knee Instrument Recalled
FDA (Devices) · 2016-02-17
- ModerateDePuy Orthopaedics Recalls Mobile Bearing Total Knee Systems Due to Packaging Damage
FDA (Devices) · 2021-04-07
- SevereDePuy ATTUNE INTUITION Impaction Handle Recalled for Fracture Risk
FDA (Devices) · 2015-01-21
- SevereDePuy Orthopaedics Recalls Specialist 2 Intramedullary Rod Instruments Due to Fracture Complaints
FDA (Devices) · 2015-10-14
- HighDePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk
FDA (Devices) · 2015-07-29
- SevereDePuy PFC SIGMA Knee Implant Recall Due to Microstructure Defects
FDA (Devices) · 2014-03-05