Align ALIGN Radial Head & Lock Screw, 24mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841506100043), received between Mar 18, 2021 and Nov 24, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  PER PREVIOUS MAUDE ADVERSE EVENT REPORT (REPORT NUMBER (B)(4)), AN ALIGN RADIAL HEAD WHICH HAD BEEN IMPLANTED FOR FOUR YEARS WAS REMOVED DUE TO BEING LOOSE WITH A PARTIALLY BACKED OUT SET SCREW, REQUIRING REVISION SURGERY.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 23631054 ↗
• MalfunctionSep 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SET SCREW BACKED OUT OF AN IMPLANTED ALIGN RADIAL HEAD, REQUIRING REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 20217939 ↗
• MalfunctionApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SET SCREW BACKED OUT OF AN IMPLANTED ALIGN RADIAL HEAD, REQUIRING REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 19093366 ↗
• MalfunctionJan 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ALIGN RADIAL HEAD DISASSOCIATED FROM THE RADIAL STEM, REQUIRING REMOVAL SIX MONTHS AFTER INITIAL IMPLANTATION.

  Patient problems: Failure of Implant; Implant Pain; Metal Related Pathology

  MAUDE report 18591986 ↗
• MalfunctionDec 8, 2023Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  AN ALIGN RADIAL HEAD WHICH HAD BEEN IMPLANTED FOR OVER FIVE YEARS WAS REMOVED DUE TO MOVEMENT OF THE RADIAL HEAD AROUND THE STEM.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 18297499 ↗
• MalfunctionNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN IMPLANTED RADIAL HEAD DISASSOCIATED FROM THE RADIAL STEM.

  Patient problems: Failure of Implant

  MAUDE report 18164916 ↗
• MalfunctionMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  RADIAL HEAD LOCKING SCREW LOOSENED. THE LOCKING SCREW WAS REPLACED SUCCESSFULLY, AND THERE ARE NO REPORTS OF FURTHER COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 16892650 ↗
• MalfunctionApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  LOCKING SCREW OF RADIAL HEAD IMPLANT LOOSENED. THE AFFECTED DEVICE WAS REMOVED AND A REVISION PROCEDURE WAS CONDUCTED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 16797424 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO LOOSENING OF THE PRODUCT. THE SCREW HAD BACKED OUT FROM THE RADIAL HEAD CAUSING IT TO BECOME LOOSE. THE HEAD AND SCREW WERE REPLACED ONTO THE EXISTING STEM. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION AND/OR THE EXPLANTED PRODUCT TO BE RETURNED BUT IS UNAVAILABLE AT THIS TIME OF FILING THE REPORT.

  Patient problems: Foreign Body In Patient; Implant Pain

  MAUDE report 11517590 ↗

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