The Recall Desk
HighFDA (Devices)·Z-0422-2014·Announced 2013-12-04

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 criteria for a High severity score.

Plain-English summary

DePuy Orthopaedics, Inc. is issuing a voluntary device correction for the SIGMA LCS HIGH PERFORMANCE MBT PUNCH NONCEMENTED Size 2-3 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 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 who have used or may have used this specific instrument should contact DePuy Orthopaedics, Inc. for further information regarding the device correction. The source text does not specify a particular action for consumers other than the issuance of the voluntary device correction.

The recalled product

Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED 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.
Category
Medical Device — Surgical Instrument
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 #950502020

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

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.

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Same hazard · foreign object retention

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