GS0008 2Y - Burn Pack - STL, Item Number 880082025
This recall is currently active, issued October 6, 2023. It was issued by Roi Cps Llc.
- Company
- Roi Cps Llc
- Recall Initiated
- September 11, 2023
- Posted
- October 6, 2023
- Recall Number
- Z-0070-2024
- Quantity
- 103 kits
- Firm Location
- Republic, MO
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Missouri
Lot / Code Info
UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16
Root Cause
Other
Action Taken
ROi CPS, LLC issued a Medical Device Correction notice to its sole consignee on 09/11/2023 by email. The notice explained the issue with the Zimmer Dermatone Blade contained in the kit, the risk, and requested the consignee affix a sticker to the exterior of the kit requesting that the blade be removed and discarded at the time of use.