The Recall Desk
SevereFDA (Devices)·Z-0539-2013·Announced 2012-12-26

Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk

Zimmer, Inc. is recalling 318 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and 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 is classified as FDA Class II and involves a structural defect in a medical device that poses a risk of significant injury (tibial bone fracture).

Plain-English summary

Zimmer, Inc. is recalling 318 units of the Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile implants, along with associated tools including the Tibial Drill Guide, Broach, and Sizing Plate. The affected products include Size C Left and Right tibial components and specific lots of the Persona Cemented Tibial Drill.

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 units were distributed nationwide in the United States and internationally to Germany and Europe.

Healthcare providers and patients who have received these specific implants or tools should contact Zimmer, Inc. for information regarding the replacement with enhanced products and instruments.

The recalled product

Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
318

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 42-5320-064-01 TIBIA SIZE C
  • LEFT Lots: 62018336
  • 62018337
  • 62033380
  • 62051020
  • 62060739
  • 62068413
  • 62076438
  • 62079740
  • 62091360
  • 62117665
  • and 77001708
  • Part Number 42-5320-064-02 TIBIA SIZE C RIGHT Lot: 62018338
  • 62018339
  • 62033383
  • 62051021
  • 62060740
  • 62060742
  • 62068415
  • 62076439

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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