Agency classClass IIOur severity:Severe FDA (Devices)·Z-0415-2014·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 be left 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 agency classified this as a Class II recall. The hazard involves a structural defect (fracturing tabs) that could result in foreign objects being left in a patient, which aligns with the rubric criteria for significant injury or structural defects.

Plain-English summary

DePuy Orthopaedics, Inc. is issuing a voluntary device correction for the SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED Size 1-1.5. This medical instrument is used to prepare the proximal tibial canal geometry to accept the final 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. The distribution included the United States and numerous international locations. The specific item number for the affected product is 950502013.

The recalled product

Product: SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 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: fracture
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 #950502013

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 · fracture