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FORZA PTC 38-1709SPRecalls & reported problems

Orthofix US LLC · 9W X 27L X 9H, 0DEG CURVED PTC IMPLANT, STERILE · Class 2 · Implant

All models of FORZA PTC (76)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18257200092208), received between May 25, 2017 and May 25, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K172437); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

  1. Nov 3, 2025Open, Classified

    Labeling contains claims that are not consistently present.

    Z-0892-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Malposition of Device1
  • Material Protrusion/Extrusion1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 25, 2017Malposition of Device; Material Protrusion/Extrusion

    INFORMATION PROVIDED, VIA MEDWATCH REPORT 5069325, CT SHOWS THAT BOTH OF THE FORZA PRC CAGES ARE EXTRUDED FROM THE DISC SPACE AND ARE COMPRESSING THE THECAL SAC. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6590196 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172437. One submission often covers many models, so check the product and lot details in each record.

  • Z-0893-2026 · Nov 3, 2025 · Open, Classified
    Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H,
  • Z-0891-2026 · Nov 3, 2025 · Open, Classified
    Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 1

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page