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FDAFDA · Food and drugs·Recall number Z-0070-2024

GS0008 2Y - Burn Pack - STL, Item Number 880082025

Published October 11, 2023 · Recall initiated: September 11, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
ROi CPS LLC
Distributor
Missouri
Lot
UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16
Risk classification
Class II
Area (FDA)
device
Country
United States

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