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 tibial bone fracture and plate loosening, which are significant injuries, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 189 units of the Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left and Size D Right. The recall includes specific part numbers and lot numbers for both left and right plates. The devices were distributed nationwide in the United States and internationally to Germany and Europe.
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. The recall also aims to prevent 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.
Healthcare providers and patients who have received these specific devices should 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 D Left; Size D 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 (5)
- Part Number 42-5399-067-01(left) Lot 62050138
- 62121496 Part Number 42-5399-067-02 (right)
- Lot 62067442
- 62075280
- 62121527
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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