Z-0864-2022 Class II Ongoing
FDA device recall Z-0864-2022 was initiated by Stradis Medical, LLC Dba Stradis Healthcare on Feb 25, 2022 and is designated Class II. Reason for recall: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. The recall status is ongoing. Affected quantity: 76 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Feb 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 units
Product Description
Total Knee Pack - Surgical Kit
Reason for Recall
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Distribution Pattern
US Nationwide distribution in the states of IN, TX, and PA.
Code Information
SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0864-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026