FDA Enforcement
Class II
Ongoing
Total Knee Pack - Surgical Kit
Recall: Z-0864-2022
·
Reported April 13, 2022
Enforcement
- Recall Number
- Z-0864-2022
- Event ID
- 89671
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stradis Medical, LLC dba Stradis Healthcare
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 13, 2022
- Initiation Date
- February 25, 2022
- Classification Date
- April 4, 2022
- Address
- 3025 Northwoods Pkwy, Peachtree Corners, GA, 30071-1524, United States
Description
Total Knee Pack - Surgical Kit
Reason
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Code Info
SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Distribution
US Nationwide distribution in the states of IN, TX, and PA.
Quantity
76 units