Align ALIGN Radial Stem, 7mm x 0mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841506100067), received between Sep 7, 2022 and Sep 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A SCREW DISENGAGED FROM A RADIAL HEAD IMPLANT. THE IMPLANT WAS REMOVED. NO PATIENT INJURY OCCURED.

  Patient problems: Failure of Implant

  MAUDE report 15372852 ↗

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