Medtronic Recalls Tibial Tray Components for Total Knee Replacement
Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated according to 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 hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling three units of Tibial Tray, Size 3, Ref 90-SRK-200300, used in total knee replacement procedures. The recall involves sterile components that may not have been passivated in accordance with the requirements of the job traveler.
The affected units were distributed to locations in Arkansas, Minnesota, and Massachusetts. The specific lot codes associated with the recall are P236112 and P239165.
Healthcare providers and patients should contact Medtronic Sofamor Danek USA Inc for further instructions regarding the disposition of these devices.
The recalled product
- Product
- TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- 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 (2)
- P236112
- P239165
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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