Class II — Skeletal Dynamics
| Recalling firm | Skeletal Dynamics, Inc |
|---|---|
| Registered facility | SKELETAL DYNAMICS, INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Report received where the Align Radial Stem fractured. |
| 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. |
| Quantity | 1700 |
| Distribution | Nationwide Distribution including GA, NJ, NM, IL, CA, OK, CO, NY, LA, OH, FL, VA, MD, MS, TX, IA, AL, WA, TN, ME, CT, WI, AZ, NE, SC, NC and Puerto Rico. |
| Initiated | 2014-10-16 |
| Classified | 2014-12-11 |
| Terminated | 2016-12-14 |
| Recall number | Z-0582-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Skeletal Dynamics (Z-0582-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69580/
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