FDA recall Z-0707-2022
Brasseler USA, Medical L.L.C. · Class II · device
Product
Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
Reason for recall
One lot of product was distributed in unsealed packaging
Distribution
US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.
Key facts
- Status
- Terminated
- Initiation date
- 2022-01-28
- Report date
- 2022-03-09
- Termination date
- 2023-02-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Savannah, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0707-2022