Zimmer Recalls Persona Knee System Tibial Sizing Plates
Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates due to a risk of tibial perforation and bone fracture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 poses a risk of tibial bone fracture, meeting the criteria for a Severe rating.
Plain-English summary
Zimmer, Inc. is recalling 188 units of the Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left and Size F Right. The recall includes specific part numbers and lot numbers for both left and right plates. The affected devices were distributed nationwide in the United States and internationally to Germany and Europe.
The recall is being conducted to reduce the risks 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 recall covers all 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.
Healthcare providers and patients should contact Zimmer, Inc. for instructions on removing and replacing the affected products with enhanced instruments.
The recalled product
- Product
- Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F 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…
- 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 (5)
- Part Number 42-5399-075-01(left) Lot 62052719
- 62121529 Part Number 42-5399-075-02 (right)
- Lot 62072309
- 62072566
- 62121524
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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