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U.S. Department of Health and Human Services

Class 2 Device Recall PremierPro Aluminum Adjustable Walker

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  Class 2 Device Recall PremierPro Aluminum Adjustable Walker see related information
Date Initiated by Firm October 01, 2018
Create Date November 20, 2018
Recall Status1 Terminated 3 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 2		 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.
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