GS0008 2Y - Burn Pack - STL, Item Number 880082025
FDA device recall Z-0070-2024 · posted 2023-10-06 · Open, Classified
Recall details
- Recalling firm
- ROi CPS LLC
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- OJJ
- Quantity affected
- 103 kits
- Distribution
- Missouri
- Date initiated
- 2023-09-11
- Date posted
- 2023-10-06
- Location
- Republic, MO
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