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Ally Uterine Positioning System (Ally UPS) used in the… recallZ-1727-2015 · CooperSurgical, Inc. · initiated May 18, 2015

Class II Terminated All recalls posted in June 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1727-2015
Recall class
Class II
Status
Terminated
Initiated by the company
May 18, 2015
Posted by the FDA
Jun 8, 2015
Recalling firm
CooperSurgical, Inc.
Quantity
5 units
Product code
LKF
FDA submissions
K141523
Distribution
Distributed in the states of CA, IL, NC, and NY.

Product description

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K141523 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page