Agency classClass IIOur severity:High FDA (Devices)·Z-0540-2013·Announced 2012-12-26

Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk

Zimmer, Inc. is recalling 518 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and 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 3/5 (High).

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 medical device with a risk of serious injury (tibial fracture) but no reported illnesses or injuries in the source text, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is recalling 518 units of the Persona The Personalized Knee System, specifically the Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile implants. 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, which could result in tibial bone fracture due to the stress riser created by a perforation. Additionally, the recall addresses the risk of tibial plate loosening. The source text does not report any specific injuries or illnesses associated with these devices.

Healthcare providers and patients who have received these specific implants or tools should contact Zimmer, Inc. for information on replacement with enhanced products and instruments. The recall covers specific part numbers and lot numbers for both left and right tibia sizes.

The recalled product

Product: Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: bone-fracture
device-failure
Affected units: 518

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 42-5320-067-01 TIBIA SIZE D
LEFT
Lot: 62018341
62018342
62030572
62030573
62033385
62051022
62068416
62076576
62079742
62091362
62103717
62103718
62110194
62117656
11007593
11007636
11007592
11007635

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 →

Same manufacturer · Zimmer, Inc.

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Same hazard · bone fracture