PremierPro Aluminum Adjustable Walker
FDA Recall Z-0487-2019 · Posted None
Recalling FirmSVS LLC
Recall StatusTerminated
Product CodeITJ
Date Initiated2018-10-01
Date Terminated2020-07-13
Product Quantity256 devices
Reason for Recall
This recall is due to a mandated order from the FDA for stock recovery and return of the imported item.
Firm 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.
Root Cause
Other
Distribution Pattern
US distribution to OH, NY,TX, PA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.