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Terminated

Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS

FDA Recall Z-1727-2015 · Posted 2015-06-08

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeLKF
Date Initiated2015-05-18
Date Terminated2015-08-07
Product Quantity5 units

Reason for Recall

Design of device may expose user to injury to fingers or body parts

Firm 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.

Root Cause

Device Design

Distribution Pattern

Distributed in the states of CA, IL, NC, and NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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