FDA-Device2023-10-11Class II

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

ROi CPS LLC
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.

Sold states
Missouri
Affected count
103 kits
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
GS0008 2Y - Burn Pack - STL, Item Number 880082025

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2024

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