Zimmer Biomet Recalls Persona Partial Knee System Spacer Block Alignment Tower
Zimmer Biomet is recalling 385 units of the Persona Partial Knee System Spacer Block Alignment Tower because an undersized mating feature could cause device connection issues and minor surgical delays.
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, but the source explicitly states the hazard is a potential delay of less than 30 minutes with an available alternative technique, fitting the criteria for a moderate risk without reported injuries.
Plain-English summary
Zimmer Biomet, Inc. is recalling 385 units of the Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35. The product is intended to aid in preparatory surgical procedures for partial knee replacements.
The recall was initiated because the mating feature on the alignment tower that connects to the spacer block was undersized. This defect could potentially lead to mating issues between the devices, which might cause a delay in surgery of less than 30 minutes. The source notes that there is an option in the surgical technique for performing limb alignment without the use of the alignment tower.
The affected units were distributed worldwide, including nationwide in the United States and in Japan and the Netherlands. Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 385
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 (4)
- 63465803
- 63762260
- 63767434
- 63799794
Distribution
Distributed nationwide across the United States.
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