Recall Z-0707-2022
Brasseler USA, Medical L.L.C. · initiated January 28, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
Codes / lots: UDI (01)00887919491033(17)260719(10)NV1MX Lot Code NV1MX
Reason for recall
One lot of product was distributed in unsealed packaging
FDA-determined cause: Under Investigation by firm
Action taken
The firm initiated the recall by telephone on 01/28/2022 and followed with a letter delivered by email. The letter explained the issue and requested the consignee set the affected product aside to be returned to the recalling firm.
Details
- Recall number
- Z-0707-2022
- Initiated
- January 28, 2022
- Terminated
- February 3, 2023
- Product code
- HTY – Pin, Fixation, Smooth
- Quantity
- 231 units
- Distribution
- US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.
- Recalling firm
- Brasseler USA, Medical L.L.C., Savannah, GA