Skeletal Dynamics 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 radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection.
Brand
Skeletal Dynamics
Lot Codes / Batch Numbers
Cat #s: ALN-RST-0700, ALN-RST-0702, ALN-RST-0704, ALN-RST-0706, ALN-RST-0708, ALN-RST-0800, ALN-RST-0802, ALN-RST-0802, ALN-RST-0804, ALN-RST-0806, ALN-RST-0808, ALN-RST-0900, ALN-RST-0902, ALN-RST-0904, ALN-RST-0906, ALN-RST-0908, ALN-RST-1000, ALN-RST-1002, ALN-RST-1004, ALN-RST-1006, ALN-RST-1008, ALN-RST-1100, ALN-RST-1102, ALN-RST-1104, ALN-RST-1106, ALN-RST-1108, Lot #s: AN0610023, AN0212065, AN0913033, AN0913034, AN0610024, AN0913035, AN0913036, AN0610025, AN0913037, AN0913038, AN0610026, AN0913039, AN0913040, AN0610027, AN0913041, AN0913042, AN0610028, AN0212066, AN0913043, AN0913044, AN0610029, AN0913045, AN0913046, AN0610030, AN0913047, AN0913048, AN0610031, AN0913049, AN0913050, AN0610032, AN0913051, AN0913052, AN0610033, AN0212067, AN0913053, AN0913054, AN0610034, AN0913055, AN0913056, AN0610035, AN0913057, AN0913058, AN0610036, AN0913059, AN0913060, AN0610037, AN0913061, AN0913062, AN0610038, AN0212068, AN0913063, AN0913064, AN0610039, AN0212069, AN0913065, AN0913066, AN0610040, AN0913067, AN0913068, AN0610041, AN0913069, AN0913070, AN0410008, AN0610042, AN0410009, AN0913071, AN0913072, AN0610043, AN0212070, AN0913073, AN0913074, AN0610044, AN0913075, AN0913076, AN0610045, AN0913077, AN0913078, AN0610046, AN0913079, AN0913080, AN0610047, AN0913081, AN0913082.
Products Sold
Cat #s: ALN-RST-0700, ALN-RST-0702, ALN-RST-0704, ALN-RST-0706, ALN-RST-0708, ALN-RST-0800, ALN-RST-0802, ALN-RST-0802, ALN-RST-0804, ALN-RST-0806, ALN-RST-0808, ALN-RST-0900, ALN-RST-0902, ALN-RST-0904, ALN-RST-0906, ALN-RST-0908, ALN-RST-1000, ALN-RST-1002, ALN-RST-1004, ALN-RST-1006, ALN-RST-1008, ALN-RST-1100, ALN-RST-1102, ALN-RST-1104, ALN-RST-1106, ALN-RST-1108; Lot #s: AN0610023, AN0212065, AN0913033, AN0913034, AN0610024, AN0913035, AN0913036, AN0610025, AN0913037, AN0913038, AN0610026, AN0913039, AN0913040, AN0610027, AN0913041, AN0913042, AN0610028, AN0212066, AN0913043, AN0913044, AN0610029, AN0913045, AN0913046, AN0610030, AN0913047, AN0913048, AN0610031, AN0913049, AN0913050, AN0610032, AN0913051, AN0913052, AN0610033, AN0212067, AN0913053, AN0913054, AN0610034, AN0913055, AN0913056, AN0610035, AN0913057, AN0913058, AN0610036, AN0913059, AN0913060, AN0610037, AN0913061, AN0913062, AN0610038, AN0212068, AN0913063, AN0913064, AN0610039, AN0212069, AN0913065, AN0913066, AN0610040, AN0913067, AN0913068, AN0610041, AN0913069, AN0913070, AN0410008, AN0610042, AN0410009, AN0913071, AN0913072, AN0610043, AN0212070, AN0913073, AN0913074, AN0610044, AN0913075, AN0913076, AN0610045, AN0913077, AN0913078, AN0610046, AN0913079, AN0913080, AN0610047, AN0913081, AN0913082.
Skeletal Dynamics is recalling Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post due to Report received where the Align Radial Stem fractured.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Report received where the Align Radial Stem fractured.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026