Class 2 Device Recall Regard

• Date Initiated by Firm: September 11, 2023
• Date Posted: October 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0070-2024
• Recall Event ID: 93077
• Product Classification: Burn kit without drug - Product Code OJJ
• Product: GS0008 2Y - Burn Pack - STL, Item Number 880082025
• Code Information: UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16
• FEI Number: 3014527682
• Recalling Firm/ Manufacturer: ROi CPS LLC; 3000 E Sawyer Rd; Republic MO 65738-2758
• Manufacturer 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.
• FDA Determined Cause: Other
• Action: ROi CPS, LLC issued a Medical Device Correction notice to its sole consignee on 09/11/2023 by email. The notice explained the issue with the Zimmer Dermatone Blade contained in the kit, the risk, and requested the consignee affix a sticker to the exterior of the kit requesting that the blade be removed and discarded at the time of use.
• Quantity in Commerce: 103 kits
• Distribution: Missouri
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.