Align Radial Stems — Class II medical device recall Z-0582-2015
Terminated recall by Skeletal Dynamics, reported 2014-12-17, distributed nationwide. Report received where the Align Radial Stem fractured.
| Recall number | Z-0582-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Skeletal Dynamics, Miami, FL, United States |
| Recall initiated | 2014-10-16 |
| Classified | 2014-12-11 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2016-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 1,700 |
| Reason classes | device malfunction |
| Lot numbers | AN0212065, AN0212066, AN0212067, AN0212068, AN0212069, AN0212070, AN0410008, AN0410009, AN0610023, AN0610024, AN0610025, AN0610026, AN0610027, AN0610028, AN0610029, AN0610030, AN0610031, AN0610032, AN0610033, AN0610034, AN0610035, AN0610036, AN0610037, AN0610038, AN0610039, AN0610040, AN0610041, AN0610042, AN0610043, AN0610044, AN0610045, AN0610046, AN0610047, AN0913033, AN0913034, AN0913035, AN0913036, AN0913037, AN0913038, AN0913039 and 43 more |
| Model numbers | ALN-RST-0700, ALN-RST-0702, ALN-RST-0704, ALN-RST-0706, ALN-RST-0708, ALN-RST-0800, 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 |
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.
Reason for recall
Report received where the Align Radial Stem fractured.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0582-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.