Total Knee Pack - Surgical Kit
- Recall Initiated
- February 25, 2022
- Recall Number
- Z-0864-2022
- Quantity
- 76 units
- Firm Location
- Peachtree Corners, GA
Reason for Recall
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Distribution
US Nationwide distribution in the states of IN, TX, and PA.
Lot / Code Info
SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Root Cause
Process change control
Action Taken
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.