Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

TIBIAL TRAY Recalled by Medtronic Sofamor Danek USA Inc Due to The alpha total knee replacement components that may...

Date: July 18, 2016
Company: Medtronic Sofamor Danek USA Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Sofamor Danek USA Inc directly.

Affected Products

TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .

Quantity: 3 units

Why Was This Recalled?

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

Where Was This Sold?

This product was distributed to 3 states: AR, MA, MN

Affected (3 states)Not affected

About Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc has 81 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report