Skeletal Dynamics: Medical Device Recall in 2014 - (Recall #: Z-0582-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 16, 2014

Date Posted: December 17, 2014

Recall Number: Z-0582-2015

Event ID: 69580

Reason for Recall:

Report received where the Align Radial Stem fractured.

Status: Terminated

Product Quantity: 1700

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated