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Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 99-56-22000)Recalls & reported problems

Orthofix Srl · DOUBLE ROW FOOTPLATE, 120MM, TL-HEX STERILE · Class 2

All models of Orthofix TrueLok Hexapod System (TL-HEX) V2.0 (15)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Jan 30, 2018Class IITerminated

    The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after September 2016. The firm determined that certain batches of the double row footplates are not compatible with the current version of the TL-HEX struts.

    Z-2063-2018 · Root cause: Device Design · Recall details · FDA record ↗

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