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.
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 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.
See all 8 products in this recall →Related recalls
Same manufacturer · Medtronic Sofamor Danek USA Inc
See all →- HighExpandable spinal cages recalled because they may lose height or collapse
FDA (Devices) · 2025-12-03
- HighGrafton DBM Orthoblend Recall Due to Sterile Packaging Inspection Issue
FDA (Devices) · 2023-11-01
- HighGrafton Plus DBM Paste medical device recalled for packaging inspection failure
FDA (Devices) · 2023-11-01
- HighGrafton DBM Demineralized Bone Matrix Recall Due to Sterile Packaging Inspection Failure
FDA (Devices) · 2023-11-01
- ModerateGrafton DBM Matrix Strips Recalled for Packaging Inspection Defect
FDA (Devices) · 2023-11-01
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighMedtronic Recalls Poly Component Trials Due to Cracked or Broken Dovetails
FDA (Devices) · 2017-03-29
- SevereMedtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails
FDA (Devices) · 2017-03-29
- HighMedtronic Spinal Distractor Rack Recalled for Manufacturing Defect
FDA (Devices) · 2023-05-17
- SevereIntegra Cadence Total Ankle System Recalled Due to Tibial Fractures
FDA (Devices) · 2017-02-22
- ModerateExactech Recalls Optetrak Tibial Trays Due to Potential Mislabeled Components
FDA (Devices) · 2012-08-01
- HighMedtronic Set Screw Retaining Driver Recalled Due to Component Sizing Issue
FDA (Devices) · 2014-02-05