Medtronic Recalls Alpha Total Knee Replacement Components for Passivation Defect
Medtronic Sofamor Danek USA Inc is recalling four units of Alpha total knee replacement femoral components that may not have been passivated according to requirements.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a manufacturing defect (lack of passivation) that poses a risk of harm (corrosion), but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling four units of Alpha total knee replacement femoral components (Reference 90-SRK-312300, Size 3L). The recall involves sterile, right-sided components.
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 affected units were distributed to facilities in Arkansas, Minnesota, and Massachusetts. The source text does not specify the number of patients implanted with these devices or report any illnesses or injuries. Consumers and healthcare providers should contact Medtronic for further instructions on how to proceed.
The recalled product
- Product
- RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 4
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)
- P239049
- P239142
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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