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U.S. Department of Health and Human Services

Class 2 Device Recall AmTryke

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  Class 2 Device Recall AmTryke see related information
Date Initiated by Firm March 27, 2015
Date Posted April 24, 2015
Recall Status1 Terminated 3 on July 10, 2017
Recall Number Z-1520-2015
Recall Event ID 70888
Product Classification Exerciser, non-measuring - Product Code ION
Product AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle.
Code Information Model: 1424, System number 50-HC-1424, Batch number 2-1301 and GM-0314.
Recalling Firm/
Manufacturer		 Amtryke LLC
4285 Regency Dr
Greensboro NC 27410-8101
For Additional Information Contact J. Joseph Copeland
336-8520052 Ext. 14
Manufacturer Reason
for Recall		 Product is being recalled due to complaints of cracked frames.
FDA Determined
Cause 2		 Under Investigation by firm
Action Consignees were notified via letter on 03/27/2015.
Quantity in Commerce 53 units
Distribution US nationwide distribution to AL, CA, FL, HI, IL, KY, KS, LA, MI, NY, OK, OR, PA, SC, TX, VA, VT and WV.
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.
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