Z-2133-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2023
- Initiation Date
- May 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 units
Product Description
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
Reason for Recall
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Panama.
Code Information
UDI/DI (EA) 10159327251772, UDI/DI (CS) 40195327251773; Lot Numbers: 23DDA761