Z-3240-2018Class II

Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

Name: Z-3240-2018 Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
Creator: Stryker GmbH
Published: 2018-07-26
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-07-26 / Terminated / root cause: software

FDA source

Stryker GmbH began a recall of Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002 on 2018-07-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3240-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-26
Posted: 2018-09-22
Terminated: 2020-05-26
Recalling firm: Stryker Corp.
Product: Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.
Root cause tag: software
FDA 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 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
Product codes and lots: Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3240-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3240-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-22

Product code KTT

K163656Class IIHoffmann LRF SystemStryker GmbH / cleared 2017-04-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)