Device product
regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit
Z-0285-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 326 kits
- Official record key
device-enforcement:Z-0285-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717104605, Lot Numbers: 91014, exp 05/01/2023; 92342, exp 07/01/2023; 91672, exp 07/01/2023
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.