Zimmer Recalls Persona Knee Trial Articular Surface Provisionals
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reported breakage. The recall covers 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 involves a medical device with reported breakage, which poses a risk of harm, but the source text does not report any injuries or illnesses, 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 UC Tibial Articular Surface Provisional Top Nonsterile components. The recall is triggered by complaints reporting breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall that covers Zimmer's corrective actions taken earlier this year concerning these TASPs.
The affected products include specific item numbers and lot numbers distributed worldwide, including the United States, Australia, Canada, Germany, India, Japan, Korea, and Singapore. The source text does not specify the exact number of units affected or the specific dates of distribution.
Consumers and healthcare providers should stop using the affected Persona Knee Trial Articular Surface Provisionals and contact Zimmer, Inc. for further instructions or replacement. The source text does not provide specific contact information or a return address.
The recalled product
- Product
- Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 70,986
Distribution
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.
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