Z-0865-2022 Class II Ongoing
FDA device recall Z-0865-2022 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: 100 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Feb 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product Description
Anterior Hip 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 570-2677; UDI H65257026770 Lot Numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21167474498, 21349479943
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0865-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026