Z-0070-2024Class II

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

Name: Z-0070-2024 GS0008 2Y - Burn Pack - STL, Item Number 880082025
Creator: ROi CPS LLC
Published: 2023-09-11
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2023-09-11 / Open, Classified

FDA source

ROi CPS LLC began a recall of GS0008 2Y - Burn Pack - STL, Item Number 880082025 on 2023-09-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0070-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-11
Posted: 2023-10-06
Recalling firm: ROi CPS LLC
Product: GS0008 2Y - Burn Pack - STL, Item Number 880082025
Product code: OJJ Burn Kit Without Drug
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 root 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
Product codes and lots: UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0070-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0070-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-05

Product code OJJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)