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.
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 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…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 138
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01
Similar recalls
- SevereZimmer Persona Knee System Recalled for Tibial Perforation Risk
FDA (Devices) · 2012-12-26
- HighZimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk
FDA (Devices) · 2012-12-26
- SevereZimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
FDA (Devices) · 2012-12-26
- SevereZimmer Recalls Persona Knee System Tibial Broach and Associated Tools
FDA (Devices) · 2012-12-26
- HighZimmer Recalls Persona Knee System Tibial Sizing Plates
FDA (Devices) · 2012-12-26
- SevereZimmer Recalls Persona Knee System Tibial Broach and Related Tools
FDA (Devices) · 2012-12-26