The Recall Desk
HighFDA (Devices)·Z-0414-2014·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 risk-of-harm product (foreign object retention) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

DePuy Orthopaedics, Inc. is issuing a voluntary device correction for the SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH CEMENTED Size 4-7. 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.

Approximately 29,235 units were distributed worldwide between 2008 and November 2013. The distribution included the United States and numerous international locations. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices.

The recalled product

Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL 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.
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 #950502012

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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