Recall Z-1727-2015 ยท LKF Cannula, Manipulator/Injector, Uterine
CooperSurgical, Inc.
Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS
| Date | Jun 8, 2015 (initiated May 18, 2015) |
| Status | Terminated |
| Reason | Design of device may expose user to injury to fingers or body parts |
| Root cause | Device Design |
| Action | CooperSurgical initiated the recall on May 18, 2015 via Fedex with confirmed delivery receipt. The letter identified the affected product and asked users to discontinue use and complete the Acknowledgement and Receipt Form to schedule a replacement. Questions contact 203.601.5200. |
| Quantity | 5 units |
| Distribution | Distributed in the states of CA, IL, NC, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141523 | ALLY UPS CooperSurgical, Inc., Nov 25, 2014 |