Zimmer Biomet Recalls Persona Partial Knee Finishing Guides
Zimmer Biomet is recalling 158 Persona Partial Knee System Size 8 Finishing Guides because they may not adequately account for shape differences, potentially causing additional surgery time or knee tightness.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes potential complications such as additional surgery time or sensation of tightness, but does not report any hospitalizations, serious injuries, or deaths, fitting the Moderate severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 158 units of the Persona Partial Knee System, Size 8, Finishing Guide. The recall involves specific item numbers 42578100801 and 42578100802, with lot numbers 63518668 and 63518669, respectively.
The recall is being conducted because the finishing guide does not adequately account for shape differences present in Size 8 of the Persona Partial Knee System. This design issue may result in additional surgery time or a sensation of tightness during knee flexion for patients.
The affected devices were distributed domestically to Arizona, California, Colorado, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, New Jersey, New Mexico, Pennsylvania, South Carolina, Texas, Washington, and Wisconsin. They were also distributed internationally to Belgium, France, Germany, Italy, Japan, the Netherlands, Spain, Sweden, and the United Kingdom. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- Product
- Persona Partial Knee System, Size 8, Finishing Guide
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 158
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 (5)
- Item No. 42578100801
- Lot No. 63518668
- UDI (01)00880304809253(10)63518668. Item No. 42578100802
- Lot No. 63518669
- UDI (01)00880304809338(10)63518669.
Distribution
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