| Date Initiated by Firm | November 09, 2021 |
|---|
| Create Date | December 22, 2021 |
|---|
| Recall Status1 |
Terminated 3 on September 29, 2025 |
| Recall Number | Z-0413-2022 |
|---|
| Recall Event ID |
89029 |
| Product Classification |
Device, impotence, mechanical/hydraulic - Product Code FHW
|
| Product | Torosa Saline-Filled Testicular Prosthesis (Size Small) |
|---|
| Code Information |
SKU# 5206102400; Catalo # (450-1325); Lot 7685283 |
| FEI Number |
2125050
|
Recalling Firm/
Manufacturer |
Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
|
| For Additional Information Contact | Coloplast Customer Service
800-788-0293 |
|---|
Manufacturer Reason
for Recall | Product is mislabeled for size. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 19 units |
|---|
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Canada. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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