FDA Device recall Z-2638-2016
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement by Medtronic Sofamor Danek Usa, citing the alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2638-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-18 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | AR, MA, MN |
Product
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Reason
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Identifiers
| code_info | P239175 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2638-2016%22
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