NavitrackER Kit A: Knee — Class II medical device recall Z-0721-2022
Ongoing recall by Orthosoft, Inc. dba Zimmer CAS, reported 2022-03-09, distributed nationwide. The product was released for distribution without passing sterilization results, which could potentially lead
| Recall number | Z-0721-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthosoft, Inc. dba Zimmer CAS, Montreal, Canada |
| Recall initiated | 2022-01-07 |
| Classified | 2022-03-03 |
| Reported by FDA | 2022-03-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, NL |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00889024304222 |
| Lot numbers | 110221A1 |
| Model numbers | 20-8000-000-07 |
Product
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Reason for recall
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.
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-0721-2022. 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.