The Recall Desk
SevereFDA (Devices)·Z-0550-2013·Announced 2012-12-26

Zimmer Persona Tibial Sizing Plate Recalled for Perforation Risk

Zimmer, Inc. is recalling Persona Tibial Sizing Plates and related 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 is classified as FDA Class II and involves a structural defect in a medical device that could result in tibial bone fracture, meeting the criteria for a Severe rating.

Plain-English summary

Zimmer, Inc. is recalling 189 units of the Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left and Right. The recall also includes all lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools such as the Tibial Drill Guide and Broach. These devices are used for patients with severe knee pain and disability due to conditions like 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. There is also a risk of tibial plate loosening. The affected products were distributed nationwide in the United States and internationally to Germany and Europe.

Healthcare providers and patients should stop using the affected devices and contact Zimmer, Inc. for replacement with enhanced products and instruments. The recall is classified as FDA Class II.

The recalled product

Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C 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 42-5399-064-01(left) Lot 62052717
  • 62079727
  • 62121519 Part 42-5399-064-02 (right) Lot 62055081
  • 62121526 Part Number 42-5399-064-02 (right)

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.

See all →

Same hazard · bone fracture

See all →