GS0008 2Y - Burn Pack - STL, Item Number 880082025
FDA Recall #Z-0070-2024 — Class II — September 11, 2023
Product Description
GS0008 2Y - Burn Pack - STL, Item Number 880082025
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.
Recalling Firm
ROi CPS LLC — Republic, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
103 kits
Distribution
Missouri
Code Information
UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated