FDA-Device2023-10-11Class II

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

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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