Medtronic Recalls Total Knee Replacement Components for Passivation Defect
Medtronic Sofamor Danek is recalling specific total knee replacement femoral components that may not have been passivated correctly.
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 hospitalizations, injuries, or illnesses. The hazard is a potential manufacturing deviation (passivation) without confirmed adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling specific total knee replacement femoral components. The affected items are identified as RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400. The recall involves a quantity of 3 units.
The recall was initiated because the components may not have been passivated in accordance with the requirements of the job traveler. Passivation is a process used to improve the corrosion resistance of metal implants. The source text does not specify any reported illnesses, injuries, or deaths associated with these units.
The distribution pattern for these units includes Arkansas (AR), Minnesota (MN), and Massachusetts (MA). The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items, nor does it list specific lot numbers or expiration dates beyond the reference number provided.
The recalled product
- Product
- RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
- Manufacturer
- Medtronic Sofamor Danek USA 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)
- P239150
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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