FDA Device recall Z-0721-2022
NavitrackER Kit A: Knee, Model Number 20-8000-000-07
- FDA Device
- Class II
- ongoing
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of NavitrackER Kit A: Knee, Model Number 20-8000-000-07 by Orthosoft, citing the product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0721-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-07 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Orthosoft |
| Distribution | US |
Product
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Reason
The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.
Identifiers
| code_info | Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0721-2022%22
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