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OrthAlign Plus 403305Recalls & reported problems

Orthalign, Inc. · Hip Registration Probe · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851977007710), received between Apr 26, 2023 and Apr 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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.

Most reported problems

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    POSSIBLE SYSTEM ACCURACY ISSUE: INCORRECT PROBE SCALE VALUE. IT WAS REPORTED BY A DISTRIBUTOR THAT DURING OPERATION OF THE DEVICE, THE PROBE SCALE VALUE SHOWED ONE WHILE AT ZERO POSITION. THE PHENOMENON OCCURRED WITH COMBINATION OF THE PROBE SCALE AND THE REFERENCE SENSOR. THIS WAS A NON-CLINICAL INCIDENT (PHENOMENON DID NOT OCCUR DURING A SURGICAL PROCEDURE).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16820859 ↗

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