Recall Z-0458-2022 ยท EZY Device, Incontinence, Mechanical/Hydraulic
Uromedica Inc.
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
| Date | Nov 22, 2021 |
| Status | Terminated |
| Reason | The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure. |
| Root cause | Nonconforming Material/Component |
| Action | Letters dated 11/22/2021 were issued via email to the consignees explaining the reason for recall. The consignee is requested to identify and remove the affected u-channel sheath and sharp trocar from circulation at their facility. The consignee will be contacted by a Uromedica representative who will schedule an in-person visit and collect the affected U-channel sheath and sharp trocar. Once the instruments have been removed from the facility, replacement instruments will be provided. |
| Quantity | 18 devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.