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OrthAlign Plus 403349Recalls & reported problems

Orthalign, Inc. · Femur Registration Tack · 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 00851977007666), received between Jul 4, 2017 and Jul 4, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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

  • Failure To Adhere Or Bond1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJul 4, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

    A SURGEON REPORTED THAT HE COMPLETED A HIPALIGN CASE THE PRIOR DAY. "EVERYTHING WAS GOING SMOOTHLY UNTIL I WENT TO TAKE MY FINAL MEASUREMENT AND REALIZED THAT MY FEMORAL TACK HAD COME LOOSE." THE SURGEON REMOVED THE TACK, BUT WAS UNABLE TO GET A FINAL MEASUREMENT FOR THE CHANGE IN LEG LENGTH. IT WASN'T IMMEDIATELY CLEAR TO THE SURGEON WHAT HAD CAUSED THE TACK TO COME LOOSE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6685425 ↗

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