Recall Z-0707-2022 ยท HTY Pin, Fixation, Smooth
Brasseler USA, Medical L.L.C.
Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
| Date | Jan 28, 2022 |
| Status | Terminated |
| Reason | One lot of product was distributed in unsealed packaging |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 231 units |
| Distribution | US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945670 | KIRSCHNER (K-WIRE), STEINMAN PINS Brasseler USA I, L.P., Mar 7, 1995 |