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FORZA PTC 38-3011SPRecalls & reported problems

Orthofix US LLC · 9W X 27L X 11H, 0DEG STRAIGH PTC IMPLANT, STERILE · Class 2 · Implant

All models of FORZA PTC (76)

Data updated Oct 18, 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 18257200091928), received between Jul 14, 2017 and Jul 14, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion 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 18, 2026.

Recalls naming this device

  1. Nov 3, 2025Class IIIOpen, 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

  • Migration or Expulsion of Device1

Patient problems

  • Nerve Damage1

Recent adverse event reports

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

  • InjuryJul 14, 2017Migration or Expulsion of Device

    INFORMATION PROVIDED STATES THAT PATIENT WAS IMPLANTED WITH FORZA PTC SPACER AND NON-ORTHOFIX SCREW AND RODS. APPROXIMATELY ONE (1) MONTH POST-OP, X-RAYS REVEALED THAT THE SPACER WAS BACKING OUT. PATIENT BECAME SYMPTOMATIC IN JANUARY AND IT WAS NOTICED VIA X-RAYS THAT SPACER WAS IMPINGING ON NERVES. REVISION SURGERY WAS PERFORMED IN MARCH TO REPLACE STRAIGHT PTC SPACER WITH CURVED PTC SPACER.

    Patient problems: Nerve Damage

    MAUDE report 6714928 ↗

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-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
  • 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 14

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Sources and updates

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