Medtronic Recalls Alpha Total Knee Replacement Tibial Tray Components
Medtronic is recalling two units of Alpha total knee replacement tibial trays that 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 the hazard involves a potential manufacturing defect (lack of passivation) in a high-risk medical device where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling two units of Alpha total knee replacement tibial trays, size 4, reference 90-SRK-200400. The recall is due to a potential failure to passivate the components in accordance with the requirements of the job traveler.
The affected units are sterile and were distributed to facilities in Arkansas, Minnesota, and Massachusetts. The specific lot codes for the recalled items are P239168 and P239169.
Healthcare providers and patients should contact Medtronic or their local FDA office for further instructions regarding the use or return of these specific components.
The recalled product
- Product
- TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- Affected units
- 2
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)
- P239168
- P239169
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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