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.
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 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, p
- Manufacturer
- Zimmer, Inc.
- 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.
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