Agency classClass IIOur severity:Severe FDA (Devices)·Z-0541-2013·Announced 2012-12-26

Zimmer Persona Knee System Recalled for Tibial Perforation Risk

Zimmer, Inc. is recalling Persona knee system tibia implants and tools to reduce the 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 significant injury, specifically tibial bone fracture and plate loosening, which aligns with the criteria for a Severe rating.

Plain-English summary

Zimmer, Inc. is recalling 591 units of the Persona The Personalized Knee System, specifically the Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile implants (Tibia Size E, Left and Right), along with associated tools including the Tibial Drill Guide, Broach, and Sizing Plate. The recall covers all lots of these specific components.

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, or traumatic arthritis.

The affected products were distributed nationwide in the United States and internationally to Germany and Europe. Healthcare providers and patients should 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 E, LEFT TIBIA SIZE E RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: bone-fracture
implant-loosening
Affected units: 591

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 42-5320-071-01 TIBIA SIZE E
LEFT
Lot 11005332
11005333
11005334
11005359
11005360
11005361
11006133
11006134
11006135
11006136
11006137
11006138
11006712
11007124
61956760
61956761
61956762
61978561

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.

See all 17 products in this recall →

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Same hazard · bone fracture