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 recall involves a structural defect in a medical device used during surgery that could result in foreign material (fractured tabs) being left in the 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 PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument. The recall is due to 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 products were distributed nationwide in the United States and internationally to numerous countries including Australia, Canada, and the United Kingdom.
Healthcare providers and patients should contact DePuy Orthopaedics, Inc. for further instructions regarding the return or replacement of the affected instruments. The specific item number for the recalled product is 950502021.
The recalled product
- Product
- SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED 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 #950502021
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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