Align ALIGN Radial Head & Lock Screw, 26mmRecalls & reported problems
Skeletal Dynamics L.L.C. · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841506100050), received between Sep 2, 2025 and Jul 31, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Naturally Worn1
Patient problems
- Failure of Implant3
- Metal Related Pathology2
- Implant Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Detachment of Device or Device Component
An implanted ALIGN Radial Head loosened after seven years, requiring revision surgery.
Patient problems: Failure of Implant
MAUDE report 50105964 ↗MalfunctionApr 23, 2026Detachment of Device or Device Component
AN IMPLANTED ALIGN RADIAL HEAD WAS LOOSE, REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant; Implant Pain; Metal Related Pathology
MAUDE report 24967882 ↗MalfunctionSep 2, 2025Detachment 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 SEVEN YEARS WAS REMOVED DUE TO MOVEMENT OF THE RADIAL HEAD AROUND THE STEM.
Patient problems: Failure of Implant; Metal Related Pathology
MAUDE report 22947521 ↗
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 · TerminatedAlign Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the
Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices
- EVOLVE 496S275Wright Medical Technology, Inc. · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall6 reports
- NA 09.405.966SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- NA 03.405.000SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- NA 09.405.250SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.263SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.570SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- EXPLOR 11-210061Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.583SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.