Recall Z-0291-2019 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Stryker GmbH
Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and disease which generally may result in joint contractures or loss of range of
| Date | Aug 28, 2018 |
| Status | Terminated |
| Reason | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured. |
| Root cause | Under Investigation by firm |
| Action | Urgent Product Recall notification letters dated 8/28/18 were sent to customers. |
| Quantity | 867 |
| Distribution | US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163656 | Hoffmann LRF System Stryker GmbH, Apr 14, 2017 |