Medtronic Alpha Total Knee Replacement Components Recalled for Passivation Defect
Medtronic is recalling Alpha total knee replacement femoral components that may not have been passivated according to job traveler requirements.
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 text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential process deviation (passivation) without confirmed adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling specific Alpha total knee replacement components. The affected items are the FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500. The recall is due to the possibility that these components were not passivated in accordance with the requirements of the job traveler.
The distribution pattern for these units includes Arkansas (AR), Minnesota (MN), and Massachusetts (MA). The specific code information associated with the recall is P239157.
Consumers and healthcare providers who have these specific components should contact Medtronic Sofamor Danek USA Inc for further instructions on how to proceed.
The recalled product
- Product
- RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
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)
- P239157
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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