TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
Reported: August 31, 2016 Initiated: July 18, 2016 #Z-2635-2016
Product Description
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
Reason for Recall
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Details
- Recalling Firm
- Medtronic Sofamor Danek USA Inc
- Units Affected
- 3 units
- Distribution
- AR, MN,MA
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 3 units.
Why was this product recalled? ▼
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2016. Severity: Moderate. Recall number: Z-2635-2016.
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