Device product
regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit
Z-0286-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 kits
- Official record key
device-enforcement:Z-0286-2023
Official wording
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Code information: UDI/DI 10194717109723, Lot Numbers: 91417, exp 2/2/2024
Distribution pattern: LA, MO, NC, FL
Derived failure modes
-
Unknown
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.