Class 2 Device Recall Hoffmann LRF

• Date Initiated by Firm: July 26, 2018
• Create Date: September 22, 2018
• Recall Status: Terminated on May 26, 2020
• Recall Number: Z-3240-2018
• Recall Event ID: 80863
• 510(K)Number: K163656
• Product Classification: Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
• Product: Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
• Code Information: Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
• FEI Number: 3002807830
• Recalling Firm/ Manufacturer: Stryker GmbH; Bohnackerweg 1; Selzach Switzerland
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 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.
• Quantity in Commerce: 233
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KTT