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Recall Observatory FDA recall evidence

Device product

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

Z-1727-2015

May 18, 2015

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 71308
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1727-2015

Official wording

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

Code information: Serial Numbers: 020015;020021;020023; 020043;020051

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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