Class 2 Device Recall Regard

• Date Initiated by Firm: January 09, 2017
• Create Date: March 24, 2017
• Recall Status: Terminated on September 28, 2018
• Recall Number: Z-1582-2017
• Recall Event ID: 76255
• Product Classification: General surgery tray - Product Code LRO
• Product: Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn
• Code Information: 024308 Exp Date 2017-04-06
• Recalling Firm/ Manufacturer: Resource Optimization & Innovation Llc; 2909 N Neergard Ave; Springfield MO 65803-6317
• For Additional Information Contact: Debbie Seilling-Ferguson; 417-820-2793
• Manufacturer Reason for Recall: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
• FDA Determined Cause: Nonconforming Material/Component
• Action: ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.
• Quantity in Commerce: 120 kits
• Distribution: US Distribution to LA and TX.
• 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.