Zimmer Recalls Persona Knee System Tibial Broach and Related Tools
Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches 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 involves a structural defect in a medical device that could result in tibial bone fracture, which constitutes a significant injury risk under the severity rubric.
Plain-English summary
Zimmer, Inc. is recalling 92 units of the Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile. 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 Sizing Plate. The affected products are identified by Part Number 42-5399-022-07 and Lots 62032102, 62087056, and 62162437.
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 devices are used with the Persona Knee System for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, or post-traumatic loss of joint configuration.
The affected products were distributed nationwide in the United States and internationally to Germany and Europe. The source text does not specify the number of reported injuries or illnesses. Consumers and healthcare providers should contact Zimmer, Inc. for information on replacing the affected products with enhanced products and instruments.
The recalled product
- Product
- Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Coll
- Manufacturer
- Zimmer, Inc.
- Affected units
- 92
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 42-5399-022-07
- Lot 62032102
- 62087056
- 62162437
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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