Z-0707-2022 Class II Terminated
FDA device recall Z-0707-2022 was initiated by Brasseler USA, Medical L.L.C. on January 28, 2022 and is designated Class II. Reason for recall: One lot of product was distributed in unsealed packaging The recall status is terminated (terminated February 3, 2023). Affected quantity: 231 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- January 28, 2022
- Termination Date
- February 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 231 units
Product Description
Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
Reason for Recall
One lot of product was distributed in unsealed packaging
Distribution Pattern
US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.
Code Information
UDI (01)00887919491033(17)260719(10)NV1MX Lot Code NV1MX