Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators duri
FDA device recall Z-1727-2015 · posted 2015-06-08 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Design of device may expose user to injury to fingers or body parts
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LKF
- Quantity affected
- 5 units
- Distribution
- Distributed in the states of CA, IL, NC, and NY.
- Date initiated
- 2015-05-18
- Date posted
- 2015-06-08
- Date terminated
- 2015-08-07
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLY UPS (K141523) | CooperSurgical, Inc. | 2014-11-25 |