Class 2 Device Recall AmTryke

• Date Initiated by Firm: March 27, 2015
• Date Posted: April 24, 2015
• Recall Status: Terminated 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.
• FEI Number: 3009020186
• 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: 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.