Medtronic Recalls Tibial Tray Components Due to Passivation Defect
Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated correctly.
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 is classified as FDA Class II, and the hazard involves a manufacturing defect in a high-risk medical device where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling three units of Tibial Tray, Size 2, Reference 90-SRK-200200, used in total knee replacement procedures. 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 locations in Arkansas, Minnesota, and Massachusetts. The specific lot codes associated with this recall are P239166 and P239167.
Healthcare providers and facilities that have received these specific components should stop using them and contact Medtronic for instructions on how to return or dispose of the product.
The recalled product
- Product
- TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
- 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 (2)
- P239166
- P239167
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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