Z-0721-2022 Class II Ongoing
FDA device recall Z-0721-2022 was initiated by Orthosoft, Inc. dba Zimmer CAS on January 7, 2022 and is designated Class II. 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 t… The recall status is ongoing. Affected quantity: 14 units US; 132 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- January 7, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units US; 132 units OUS
Product Description
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
Code Information
Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1