Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
Zimmer, Inc. is recalling 346 units of 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 constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Zimmer, Inc. is recalling 346 units of the Persona The Personalized Knee System, specifically the Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile implants (Tibia Size G, Left and Right), along with associated tools including the Tibial Drill Guide, Broach, and Sizing Plate. The recall covers all lots of the Persona Cemented Tibial Drill and the specified tibia implants.
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 affected devices are indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, traumatic arthritis, and other specified joint disorders.
The recalled products were distributed nationwide in the United States and internationally to Germany and Europe. Consumers and healthcare providers should stop using the affected devices and contact Zimmer, Inc. for replacement with enhanced products and instruments.
The recalled product
- Product
- Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE G, LEFT TIBIA SIZE G 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
- 346
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 42-5320-079-01 TIBIA SIZEG
- LEFT
- Lot 11007106
- 62018351
- 62018352
- 62033397
- 62051024
- 62060746
- 62068421
- 62076590
- 62079768
- 62079769
- 62091369
- 62117663
- 11007728
- 62144994 Part Number 42-5320-079-02 TIBIA SIZEG
- RIGHT
- Lot: 11007168
- 11007488
- 62018353
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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