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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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