Zimmer Biomet Recalls Persona Knee System Components Due to Missing Parts
Zimmer Biomet is recalling 3 units of the Persona Knee System because the set screw and taper plug were missing from the packaging.
What this means for you
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. The hazard involves missing components (set screw and taper plug) which is a packaging/assembly issue rather than a direct contamination or structural failure causing immediate harm, fitting the criteria for moderate severity.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3 units of the Persona The Personalized Knee System, specifically the PSN TIB STM 5 DEG SZ D R model. The affected item number is 42-5320-067-02, and the lot number is 63236047. This medical device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, or polyarthritis.
The recall was initiated after a complaint was received indicating that the set screw or taper plug was not included in the box. An investigation confirmed that the entire lot 63236047 was missing these specific components. The distribution pattern for these units is listed as Non-USA Customer.
Consumers and healthcare providers who have these specific units should contact Zimmer Biomet, Inc. for further instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 3
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 (1)
- Item# 42-5320-067-02 Lot # 63236047
Distribution
Distribution scope not specified by the agency.
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