Recall Z-0487-2019 ยท ITJ Walker, Mechanical
SVS LLC
PremierPro Aluminum Adjustable Walker
| Date | Oct 1, 2018 |
| Status | Terminated |
| Reason | This recall is due to a mandated order from the FDA for stock recovery and return of the imported item. |
| 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 | 256 devices |
| Distribution | US distribution to OH, NY,TX, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.