Device product
regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit
Z-0319-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54 kits
- Official record key
device-enforcement:Z-0319-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717105763, Lot Numbers: 91403, exp 2/4/2024; 92161, exp 4/12/2024
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.