Orthosoft, Inc. dba Zimmer CAS Recall 89619
Description: NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Orthosoft, Inc. dba Zimmer CAS Recall 89619 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0721-2022 |
| Event ID | 89619 |
| Event Description | NavitrackER Kit A: Knee, Model Number 20-8000-000-07, |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands. |
| Quantity | 14 units US; 132 units OUS |
| Recall 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. |
| Device Classification | 20220309 |
| Device Code Info | Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1 |
| Center Classification Date | 20220303 |
| Recall Initiation Date | 20220107 |
| Recalling Firm | Orthosoft, Inc. dba Zimmer CAS |
| Initial Notification | Letter |
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