Device product
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Z-0070-2024
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 93077
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 103 kits
- Official record key
device-enforcement:Z-0070-2024
Official wording
Reason: Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.
Code information: UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16
Distribution pattern: Missouri
Derived failure modes
-
Unknown
Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.