Zimmer Persona Stemmed 5 Degree Cemented Tibia Recalled for Cleaning Failure
Zimmer, Inc. is recalling 138 units of Persona Stemmed 5 Degree Cemented Tibia knee components due to a cleaning process validation failure.
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 due to a cleaning process validation failure. No specific injuries, illnesses, or deaths are reported in the source text, and the hazard is procedural rather than a direct structural defect or high-risk pathogen, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer, Inc. is recalling 138 units of the Persona Stemmed 5 Degree Cemented Tibia medical device. This device is indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis. The recall is being conducted because of a cleaning process validation failure.
The affected units were distributed nationwide in the United States and in Austria, Belgium, Switzerland, Germany, France, the United Kingdom, Italy, and South Africa. The recall covers specific part numbers and lot numbers, including Part Number 42-5320-079-02 (Lot 62613813) and Part Number 42-5320-071-02 (Lot 62625781).
Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the return or replacement of these devices. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femor
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 138
Distribution
Distributed nationwide across the United States.
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