Zimmer Recalls Persona Knee System Tibial Sizing Plates
Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential tibial bone fracture) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Zimmer, Inc. is recalling 189 units of the Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left and Right. The affected products are identified by Part Number 42-5399-083-01 (left) with Lots 62052720 and 62121504, and Part Number 42-5399-083-02 (right) with Lots 62061018 and 62121506.
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, as well as tibial plate loosening. The affected lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments.
The devices were distributed nationwide in the United States and internationally to Germany and Europe. The Persona Knee System is used for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis. Healthcare providers and patients should contact Zimmer, Inc. for information on the replacement of these devices.
The recalled product
- Product
- Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H 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
- 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 42-5399-083-01(left) Lot 62052720
- 62121504 Part Number 42-5399-083-02 (right)
- Lot 62061018
- 62121506
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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