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FORZA PTC 38-7010SPRecalls & reported problems

Orthofix US LLC · 9W X 23L X 10H, 8DEG STRAIGHT PTC IMPLANT, STERILE · Class 2 · Implant

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

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, 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

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 X 1
  • 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,

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.