The Recall Desk
HighFDA (Devices)·Z-2298-2014·Announced 2014-08-27

Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.

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 medical device with reported breakage, which poses a risk of harm during surgery, but the source does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is recalling the Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile (TASPs). The recall is being conducted because the company received complaints reporting breakage of these trial components. This is a retrospective recall that covers corrective actions Zimmer took earlier in the year regarding these specific devices.

The affected products are identified by Item Number 42517000410 and specific lot numbers including 62024975, 62043546, and others listed in the official notice. The recall covers 70,986 distribution events. Distribution was worldwide, including the United States (nationwide, DC, and Puerto Rico) and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.

These are nonsterile provisional components used during knee surgery. Consumers and healthcare providers should stop using the affected lots and contact Zimmer, Inc. for further instructions or replacement.

The recalled product

Product
Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
70,986

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

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Same hazard · breakage

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