FDAClass IIOctober 11, 2023

GS0008 2Y - Burn Pack - STL recall

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

Why was GS0008 2Y - Burn Pack - STL recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16

Product
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Recalling firm
ROi CPS LLC
Quantity
103 kits
Distribution
Missouri
Recall date
October 11, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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