Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
Recall
- Recall Number
- Z-3240-2018
- Event Number
- 80863
- Firm
- Stryker GmbH Bohnackerweg 1 Selzach Switzerland
- FEI Number
- 3002807830
- Product Code
- KTT
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- July 26, 2018
- Terminated
- May 26, 2020
Description
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
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.
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 correction per day is desired, the Correction time may be overridden by entering the desired number of days in the Override correction time field on the Limiting Anatomical Structure (LAS) page. If the correction time is overridden, the correction plan will be accurate regardless of the number of corrections. Continue to evaluate the patients through routine follow-up radiographs for alignment and distraction.
Nationwide
233