TIBIAL TRAY — Class II medical device recall Z-2637-2016
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2016-08-31, distributed in AR, MA, MN. The alpha total knee replacement components that may have not been passivated in accordance with the requireme
| Recall number | Z-2637-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2016-07-18 |
| Classified | 2016-08-23 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2016-11-22 |
| Distributed | AR, MA, MN |
| Quantity | 2 units |
| Model numbers | 90-SRK-200400 |
Product
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2637-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.