Recall Z-1808-2020 ยท KOA Surgical Instruments, G-U, Manual (And Accessories)
Uromedica Inc.
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
| Date | Apr 10, 2019 |
| Status | Terminated |
| Reason | Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths. |
| Root cause | Nonconforming Material/Component |
| Action | Uromedica sent a notification to the customers via email and letter instructing them to identify the affected sets and returned them to Uromedica within 10 business days. Uromedica will provide for the return shipping of the affected tool set and replace if free of charge. |
| Quantity | 11 tool sets |
| Distribution | Nationwide distribution to the following states: CA, GA, FL, MI, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.