The Recall Desk
SevereFDA (Devices)·Z-0554-2013·Announced 2012-12-26

Zimmer Recalls Persona Knee System Tibial Sizing Plates

Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

What this means for you

Illness, injury, or structural failure has been reported. 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 rubric criteria for a structural defect or significant injury risk.

Plain-English summary

Zimmer, Inc. is recalling 189 units of the Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left and Right. The affected devices are identified by Part Numbers 42-5399-079-01 and 42-5399-079-02 and specific lot numbers listed in the agency record. These devices are used with the Persona Knee System for 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 the stress riser created by a perforation, as well as tibial plate loosening. The recall includes all lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate.

The affected devices were distributed nationwide in the United States and internationally to Germany and Europe. Healthcare providers and patients should 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 G Left; Size G 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, p
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
189

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 (4)

  • Part Number 42-5399-079-01(left) Lot 62061017
  • 62121502 Part Number 42-5399-079-02 (right) Lot 62072310
  • 62072567
  • 62121503

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 →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · bone fracture

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