FDA Medical Device Recalls (openFDA)
ROi CPS LLC: GS0008 2Y - Burn Pack - STL, Item Number 880082025
- Recall number
- Z-0070-2024
- Recalling firm
- ROi CPS LLC
- Product
- GS0008 2Y - Burn Pack - STL, Item Number 880082025
- Status
- Open, Classified
- Initiated
- 2023-09-11
- Posted
- 2023-10-06
- Terminated
- not on file
- Reason
- 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.
- 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
- 103 kits
- Distribution
- Missouri
- Lot, serial or model codes
- UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJJ
- Firm FEI
- 3014527682
- Firm city
- Republic
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28