Recall Z-3240-2018 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Stryker GmbH
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
| Date | Jul 26, 2018 |
| Status | Terminated |
| Reason | When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial portion of the plan. |
| Root cause | Under Investigation by firm |
| Action | Stryker contracted Third Party: Stericycle Contact Center, 6026 Lakeside Blvd., Indianapolis, IN 46278 notified affected hospitals via 2-day UPS (with return receipt) on July 26, 2018 All affected surgeon users notified via email with Request read Receipt and Request delivered Receipt options selected. Provided the following: if you have selected the Correct Axial First button, with multiple corrections per day, redo the correction plan by either of the following methods: a. Calculate the correction plan with one correction per day selected on the Correction Plan page or b. If more than one |
| Quantity | 233 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163656 | Hoffmann LRF System Stryker GmbH, Apr 14, 2017 |