Medtronic Recalls Alpha Total Knee Replacement Tibial Tray Components
Medtronic is recalling specific Alpha total knee replacement tibial trays that may not have been passivated according to manufacturing 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 the hazard involves a potential manufacturing defect in a high-risk medical implant where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling Alpha total knee replacement tibial trays, size 5, reference 90-SRK-200500. The recall involves one unit per lot, identified by code P239175. These components were distributed to facilities in Arkansas, Minnesota, and Massachusetts.
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 ensure the stability and safety of metal implants.
Healthcare providers and patients who have received these specific components should contact Medtronic or their healthcare provider for further instructions on whether the implant needs to be removed or replaced.
The recalled product
- Product
- TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 1
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)
- P239175
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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