FDA Medical Device Recalls (openFDA)
Stryker GmbH: Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
- Recall number
- Z-3240-2018
- Recalling firm
- Stryker GmbH
- Product
- Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
- Status
- Terminated
- Initiated
- 2018-07-26
- Posted
- not on file
- Terminated
- 2020-05-26
- 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 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
- 233
- Distribution
- Nationwide
- Lot, serial or model codes
- Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
- 510(k) numbers
- ["K163656"]
- PMA numbers
- not on file
- Product code
- KTT
- Firm FEI
- 3002807830
- Firm city
- Selzach
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28