The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2297-2014·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 (TASPs) after receiving complaints of breakage. This is a retrospective recall covering corrective actions taken earlier this year.

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 is classified as FDA Class II, and the hazard involves the breakage of a medical device used in surgery, which poses a risk of harm even though specific injuries or illnesses are not explicitly reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling the Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile (TASPs). The recall is being conducted because the company received complaints reporting breakage of these trial articular surface provisionals.

This is a retrospective recall that covers Zimmer's corrective actions taken earlier this year. The affected products include various sizes and configurations of the TASP L and TASP R Bottom components, specifically the +0MM and +6MM variants for CD, EF, GH, and J models.

The recall involves 70,986 distribution events. The products were distributed worldwide, including nationwide in the United States (including DC and Puerto Rico) and in the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore. Consumers and healthcare providers should stop using these specific trial components and contact Zimmer, Inc. for further instructions.

The recalled product

Product
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J…
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 →

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