Agency classClass IIOur severity:High FDA (Devices)·Z-2301-2014·Announced 2014-08-27

Zimmer Recalls Persona Knee System Trial Components Due to Breakage

Zimmer, Inc. is recalling Persona Knee System trial components after receiving complaints about breakage. The recall covers distribution events in the US and several international countries.

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 reported breakage, which poses a risk of harm to patients during surgery, but the source text does not report any injuries, illnesses, or fatalities. This aligns with the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is recalling specific lots of the Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top (TASP) components. The recall is triggered by complaints reporting breakage of these trial articular surfaces. This is a retrospective recall covering corrective actions taken by the company earlier in the year.

The affected products include nonsterile TASP components with specific item numbers and lot numbers. The distribution pattern indicates worldwide distribution, including nationwide distribution in the United States (including DC and Puerto Rico) and specific countries such as Australia, Canada, Germany, India, Japan, Korea, and Singapore. The source text notes 70,986 distribution events.

Healthcare providers and patients should contact Zimmer, Inc. for further information regarding the recall and corrective actions. The source text does not specify a direct consumer action other than the general recall context, but medical professionals should verify if they have used the affected lots.

The recalled product

Product: Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: breakage
device-failure
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 →

Same manufacturer · Zimmer, Inc.

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