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Align Radial Stems, Prosthesis, Elbow, Hemi recallZ-0582-2015 · Skeletal Dynamics · initiated Oct 16, 2014

Class II Terminated All recalls posted in December 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Skeletal Dynamics or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Report received where the Align Radial Stem fractured.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0582-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 16, 2014
Posted by the FDA
Dec 12, 2014
Recalling firm
Skeletal Dynamics
Quantity
1700
Product code
KWI
FDA submissions
K092721
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 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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Other devices under the same FDA submission

6 devices cleared under K092721 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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