Device recall
Z-1977-2019: Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No…
FDA device recall · Class II · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-1977-2019 |
|---|---|
| Recall event | 83105 |
| Product | Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic… |
| Product code | HEW |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 19, 2020 |
| 510(k) numbers | K180429 |
| FEI number | 1216677 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database