Recall Z-2105-2016 ยท INP Tips And Pads, Cane, Crutch And Walker
Medical Depot Inc.
Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
| Date | Feb 17, 2016 |
| Status | Terminated |
| Reason | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground |
| Root cause | Nonconforming Material/Component |
| Action | On February 17, 2016, drive DeVilbiss Healthcare issued a preliminary notice their customers informing them of the situation via courier service. Secondly, On February 25, 2016, drive DeVilbiss Healthcare distributed another notice informing customers that the potential issue was confirmed to a limited number of lots. Customers were advised to quarantine all products in inventory as replacement products will be provided. The company notified customers that they will commence shipping orders for the product on Monday, February 29, 2016. Customers were also advised that a substantial invent |
| Quantity | 123,125 pairs |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.