Agency classClass IIOur severity:Severe FDA (Devices)·Z-0552-2013·Announced 2012-12-26

Zimmer Persona Knee System Tibial Sizing Plates Recalled for Perforation Risk

Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

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 that could result in tibial bone fracture, meeting the criteria for a Severe rating (score 4) due to the potential for significant injury.

Plain-English summary

Zimmer, Inc. is recalling 188 units of the Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left and Right. The recall includes specific part numbers and lot numbers for both left and right plates. These devices are used in patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis.

The recall is being conducted to reduce the risk of tibial perforation, which could result in tibial bone fracture due to stress risers created by the perforation. The recall also aims to prevent tibial plate loosening. The affected products were distributed nationwide in the United States and internationally to Germany and Europe.

Consumers and healthcare providers should stop using the affected Tibial Sizing Plates and contact Zimmer, Inc. for replacement with enhanced products and instruments.

The recalled product

Product: Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: bone-fracture
structural-defect
Affected units: 188

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 (3)

Part Number 42-5399-071-01(left) Lot 62052718
62121498 Part Number 42-5399-071-02 (right) Lot 62055082
62121499

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Zimmer, 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 17 products in this recall →

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Same hazard · bone fracture