GS0008 2Y - Burn Pack - STL, Item Number 880082025 recallZ-0070-2024 · ROi CPS LLC · initiated Sep 11, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ROi CPS LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0070-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 11, 2023
- Posted by the FDA
- Oct 6, 2023
- Recalling firm
- ROi CPS LLC
- Quantity
- 103 kits
- Product code
- OJJ
- Distribution
- Missouri
Product description
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Code information (models, lots, serial numbers)
UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ GS00082YRoi Cps, LLC · Burn Kit Without Drug1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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