Recall Z-0070-2024— ROi CPS LLC
Class II · Ongoing
Class II FDA medical device recall by ROi CPS LLC, initiated 2023-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: GS0008 2Y - Burn Pack - STL, Item Number 880082025. 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..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-11
- Firm location
- Republic, MO, United States
Product description
GS0008 2Y - Burn Pack - STL, Item Number 880082025
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.