Stradis Medical, LLC dba Stradis Healthcare Total Knee Pack - Surgical Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Total Knee Pack - Surgical Kit
Brand
Stradis Medical, LLC dba Stradis Healthcare
Lot Codes / Batch Numbers
SKU/Part Number 570-2676, UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Products Sold
SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Stradis Medical, LLC dba Stradis Healthcare is recalling Total Knee Pack - Surgical Kit due to The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Recommended Action
Per FDA guidance
A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026