Recall Z-0413-2022 ยท FHW Device, Impotence, Mechanical/Hydraulic
Coloplast Manufacturing US, LLC
Torosa Saline-Filled Testicular Prosthesis (Size Small)
| Date | Nov 9, 2021 |
| Status | Terminated |
| Reason | Product is mislabeled for size. |
| Root cause | Process control |
| Action | A customer letter was issued to affected consignees dated 11/09/2021. Consignees are asked to move all inventory to quarantine and returned all impacted product within 10 days of letter receipt. If the product was further distributed, the consignee is directed to notify downstream customers of the recall. An Acknowledgement and Receipt Form should be completed indicating the quantity that will be returned. This should be completed even if there is no inventory. |
| Quantity | 19 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.