Class 2 Device Recall PremierPro Aluminum Adjustable Walker

• Date Initiated by Firm: October 01, 2018
• Create Date: November 20, 2018
• Recall Status: Terminated on July 13, 2020
• Recall Number: Z-0487-2019
• Recall Event ID: 81367
• Product Classification: Walker, mechanical - Product Code ITJ
• Product: PremierPro Aluminum Adjustable Walker
• Code Information: Model 7803. Lot number:: CJH05041. Serial number: J1805000577-J1805000864
• Recalling Firm/ Manufacturer: SVS LLC; 14120 Ballantyne Corporate Pl Ste 425; Charlotte NC 28277-2891
• For Additional Information Contact: Brenda Miller; 704-391-3842
• Manufacturer Reason for Recall: This recall is due to a mandated order from the FDA for stock recovery and return of the imported item.
• FDA Determined Cause: Other
• Action: SVS LLC, dba S2S Global notified customers initially via telephone on about 10/01/2018 and followed up with a "Notice of Product Recall" letter on about 10/03/2018. The letter requested customers check inventory for affected walkers, quarantine any on hand, make arrangements to return the affected walkers, and complete and return the Medical Device Acknowledgement & Return Response Form.
• Quantity in Commerce: 256 devices
• Distribution: US distribution to OH, NY,TX, PA
• 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.