Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk
Zimmer, Inc. is recalling 195 Persona knee system tibia implants and associated 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 aligns with the rubric criteria for 'Severe' (structural defect or significant injury reports).
Plain-English summary
Zimmer, Inc. is recalling 195 units of the Persona The Personalized Knee System, specifically the Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile implants (Tibia Size H, Left and Right). The recall also includes associated tools such as the Tibial Drill Guide, Broach, and Sizing Plate. The affected products 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. A perforation can create a stress riser that may result in tibial bone fracture or tibial plate loosening. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and patients who have received these specific implants or used the associated tools should contact Zimmer, Inc. for information on replacement with enhanced products and instruments. The recall covers specific lot numbers for both left and right tibia components, as detailed in the agency's structured product information.
The recalled product
- Product
- Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
- Manufacturer
- Zimmer, Inc.
- Affected units
- 195
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 (20)
- Part Number 42-5320-083-01 TIBIA SIZE H
- LEFT
- Lot: 11006513
- 11006722
- 11007119
- 62018828
- 62018829
- 62033403
- 62060748
- 62068423
- 62076595
- 62079771
- 62091371
- 62110207
- 62117667 Part Number 42-5320-083-02 TIBIA SIZE H
- RIGHT
- Lot: 11007062
- 11007123
- 62018830
- 62018831
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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