CLASS II Device recall · Reported 17 Dec 2014 · FDA Enforcement Report

Align Radial Stems, Prosthesis, Elbow recalled by Skeletal Dynamics

Skeletal Dynamics is recalling Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for, distributed nationwide in the US. The recall was initiated on 16 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCat #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.

Quantity recalled1700

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0582-2015
FDA event ID: 69580
Recalling firm: Skeletal Dynamics, Miami, FL
Classification: Class II
Status: Terminated
Recall initiated: 16 Oct 2014
FDA classified: 11 Dec 2014
Reported: 17 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Oct 2014	Recall initiated by company
11 Dec 2014	Classified by FDA	+56 days
17 Dec 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Report received where the Align Radial Stem fractured.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arizona California Colorado Connecticut Florida Georgia Iowa Illinois Louisiana Maryland Maine Mississippi North Carolina Nebraska New Jersey New Mexico New York Ohio Oklahoma

Questions about this recall

Is Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for recalled?

Yes. Skeletal Dynamics recalled Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for on 16 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0582-2015.

Why was it recalled?

Report received where the Align Radial Stem fractured.

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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