The Recall Desk
SevereFDA (Devices)·Z-0541-2013·Announced 2012-12-26

Zimmer Persona Knee System Recalled for Tibial Perforation Risk

Zimmer, Inc. is recalling Persona knee system tibia implants and tools 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 poses a risk of significant injury, specifically tibial bone fracture and plate loosening, which aligns with the criteria for a Severe rating.

Plain-English summary

Zimmer, Inc. is recalling 591 units of the Persona The Personalized Knee System, specifically the Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile implants (Tibia Size E, Left and Right), along with associated tools including the Tibial Drill Guide, Broach, and Sizing Plate. The recall covers all lots of these specific components.

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, or tibial plate loosening. The affected devices are indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, or traumatic arthritis.

The affected products 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, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
591

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 (20)

  • Part Number 42-5320-071-01 TIBIA SIZE E
  • LEFT
  • Lot 11005332
  • 11005333
  • 11005334
  • 11005359
  • 11005360
  • 11005361
  • 11006133
  • 11006134
  • 11006135
  • 11006136
  • 11006137
  • 11006138
  • 11006712
  • 11007124
  • 61956760
  • 61956761
  • 61956762
  • 61978561

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

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Same hazard · bone fracture

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