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U.S. Department of Health and Human Services

Class 2 Device Recall Align Radial Stem

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  Class 2 Device Recall Align Radial Stem see related information
Date Initiated by Firm October 16, 2014
Date Posted December 12, 2014
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-0582-2015
Recall Event ID 69580
510(K)Number K092721  
Product Classification Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
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.
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.
Recalling Firm/
Manufacturer		 Skeletal Dynamics
8905 Sw 87th Ave Ste 201
Miami FL 33176-2227
For Additional Information Contact Mario Arbesu
305-596-7585 Ext. 7026
Manufacturer Reason
for Recall		 Report received where the Align Radial Stem fractured.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWI and Original Applicant = SKELETAL DYNAMICS, LLC
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