Z-0582-2015Class II

Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic...

Name: Z-0582-2015 Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic...
Creator: Skeletal Dynamics
Published: 2014-10-16
License: https://open.fda.gov/license/

Skeletal Dynamics, Inc / initiated 2014-10-16 / Terminated / root cause: design

FDA source

Skeletal Dynamics began a recall of Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and... on 2014-10-16. FDA classified it as Class II and gives the reason as "Report received where the Align Radial Stem fractured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0582-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-16
Posted: 2014-12-12
Terminated: 2016-12-14
Recalling firm: Skeletal Dynamics, Inc
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.
Product code: KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Reason for recall: Report received where the Align Radial Stem fractured.
Root cause tag: design
FDA root cause: Device Design
Action: Skeletal Dynamic sent an Urgent Medical Device Safety Alert dated October 16, 2014, to all affected customers via certified mail. The Safety Alert included the warning "that radial head prostheses cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue. Failure of the component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union or excessive loads (estimated body weight equivalent of 350 lbs or greater)" with instructions to notify any surgeons that have used the product. A response form has been included with instructions to return the signed form to acknowledge the receipt and understanding of the new warning. Product labeling has been revised to include these labels in future shipments. Customers with questions were instructed to contact Customer Service at 877-753-5396 for assistance. For questions regarding this recall call 305-596-7585, ext 7026.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0582-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0582-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-11

Product code KWI

K092721Class IIAlign Radial Head SystemSkeletal Dynamics, LLC / cleared 2010-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)