Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0487-2019Class II

PremierPro Aluminum Adjustable Walker

SVS LLC / initiated 2018-10-01 / Terminated

SVS LLC began a recall of PremierPro Aluminum Adjustable Walker on . FDA classified it as Class II and gives the reason as "This recall is due to a mandated order from the FDA for stock recovery and return of the imported item". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0487-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
SVS LLC
Product
PremierPro Aluminum Adjustable Walker
Product code
ITJ Walker, Mechanical
Reason for recall
This recall is due to a mandated order from the FDA for stock recovery and return of the imported item.
FDA root 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
Product codes and lots
Model 7803.  Lot number:: CJH05041.  Serial number: J1805000577-J1805000864

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0487-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0487-2019Class IITerminatedVoluntary: Firm initiated