Recall Z-0884-2020 ยท HTY Pin, Fixation, Smooth
Brasseler USA I Lp
Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.
| Date | Dec 11, 2019 |
| Status | Terminated |
| Reason | 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins. |
| Root cause | Labeling mix-ups |
| Action | Initial contact to affected consignees was made on 12/11/2019 by telephone to provide notification of the labeling error and arrange for replacement product. Recall letter also sent to affected consignees. |
| Quantity | 56 packs of 6 |
| Distribution | US: AZ, AR, FL |
| 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 |