DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
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.
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 with a risk of harm (foreign object retention) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
DePuy Orthopaedics, Inc. is issuing a voluntary device correction for the SIGMA LCS HIGH PERFORMANCE MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument. The recall is being conducted because of the potential for tabs on the connection end of the instrument to fracture and be left in the patient during use.
The affected instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray during total knee arthroplasty. The recall covers 29,235 units manufactured between 2008 and November 2013. The product was distributed nationwide in the United States and internationally to numerous countries, including Australia, Canada, the United Kingdom, and Germany.
Healthcare providers and patients should contact DePuy Orthopaedics for further instructions regarding the return or replacement of the affected instruments. The source text does not specify the number of reported injuries or illnesses associated with this defect.
The recalled product
- Product
- SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 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.
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 #950502018
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.
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