Class 2 Device Recall Flexgard, offtheshelf knee brace

• Date Initiated by Firm: February 14, 2003
• Date Posted: March 19, 2003
• Recall Status: Terminated on August 22, 2003
• Recall Number: Z-0658-03
• Recall Event ID: 25659
• Product Classification: Joint, Knee, External Brace - Product Code ITQ
• Product: Flexgard, off-the-shelf knee brace, product number 14761106
• Code Information: Product number 14761106, Lot numbers: 53078 and 53985
• Recalling Firm/ Manufacturer: De Royal Industries; 870 Industrial Way; San Luis Obispo CA 93401
• For Additional Information Contact: Mr. Tracy Edmundson; 865-938-7828
• Manufacturer Reason for Recall: Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.
• FDA Determined Cause: Other
• Action: The firm notified its consignees by letter dated 2/19/2003 asking them to return any in-stock product and to contact their consignees if the product was further distributed.
• Quantity in Commerce: 13
• Distribution: ID, CA, NC, TX, SC, NM, GA and TN
• 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.