FDA recall Z-0070-2024

ROi CPS LLC · Class II · device

Product

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.

Distribution

Missouri

Key facts

Status
Ongoing
Initiation date
2023-09-11
Report date
2023-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2024