Agency classClass IIOur severity:Severe FDA (Devices)·Z-0417-2014·Announced 2013-12-04

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 surgical instrument that could result in foreign material being left in a patient, which aligns with the rubric criterion for 'structural vehicle defect' or 'significant injury/property-damage reports' (interpreted here as significant physical harm risk from a structural failure in a medical device).

Plain-English summary

DePuy Orthopaedics, Inc. is issuing a voluntary device correction for the SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED (Item #950502015). This medical instrument is used during total knee arthroplasty to prepare the proximal tibial canal geometry to accept the final tibial tray.

The recall is due to the potential for tabs on the connection end of the instrument to fracture and be left in the patient. The affected units were distributed worldwide, including nationwide in the United States and in numerous international markets, from 2008 through November 2013.

Healthcare providers and patients should contact DePuy Orthopaedics for further instructions regarding the correction of these devices.

The recalled product

Product: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL 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.
Category: Medical Device — Surgical Instrument
Hazard: structural-failure
foreign-object

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 #950502015

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 →

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · structural failure