Z-0866-2022 Class II Ongoing
FDA device recall Z-0866-2022 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: 348 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Feb 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 348 units
Product Description
Coryell Memorial Hosp Total, Joint 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 690-260; UDI M7526902600 Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0866-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026