DePuy Recalls Knee Instruments Due to Potential Tab Fracture
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs may fracture and remain in patients.
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 injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
DePuy Orthopaedics, Inc. is issuing a voluntary device correction for the SIGMA LCS HIGH PERFORMANCE MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument. This 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 source text does not report any specific injuries or illnesses associated with this defect.
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 instructions on the device correction.
The recalled product
- Product
- SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT 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.
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 #950502017
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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