Recall Z-0070-2024 ยท OJJ Burn Kit Without Drug
ROi CPS LLC
GS0008 2Y - Burn Pack - STL, Item Number 880082025
| Date | Oct 6, 2023 (initiated Sep 11, 2023) |
| Status | Open, Classified |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.