Align ALIGN Radial Stem, 9mm x 0mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841506100166), received between Mar 31, 2026 and Apr 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 other recall cover devices cleared under the same FDA submission (K092721); 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Improper or Incorrect Procedure or Method

  A PATIENT IS EXPERIENCING ELBOW PAIN WHILE LIFTING WEIGHTS ONE YEAR AFTER IMPLANTATION OF AN ALIGN RADIAL HEAD CONSTRUCT, REQUIRING REVISION SURGERY.

  Patient problems: Arthralgia

  MAUDE report 24990542 ↗
• MalfunctionMar 31, 2026Osseointegration Problem

  AN IMPLANTED ALIGN RADIAL STEM LOOSENED AFTER FIVE MONTHS, REQUIRING REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 24747304 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092721. One submission often covers many models, so check the product and lot details in each record.

• Z-0582-2015 · Oct 16, 2014 · Terminated
  Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the