Medtronic Recalls Alpha Total Knee Replacement Components for Passivation Issues
Medtronic is recalling three units of Alpha total knee replacement femoral components because they 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 3/5 (High).
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 is classified as FDA Class II and involves a medical device where a manufacturing process deviation (passivation) could pose a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling three units of the Alpha total knee replacement femoral component, size 3R, reference 90-SRK-311300. The recall was initiated because the components may not have been passivated in accordance with the requirements of the job traveler.
The affected units were distributed to facilities in Arkansas, Minnesota, and Massachusetts. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and facilities that have received these specific components should stop using them and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, 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)
- P239050
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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