International Medical Devices Database

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

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Type of Event
Recall
Event ID
68326
Event Risk Class
Class 2
Event Number
Z-1712-2014
Event Initiated Date
2014-04-30
Event Date Posted
2014-06-04
Event Status
Terminated
Event Country
United States
Event Terminated Date
2014-12-01
Event Source
USFDA
Event Source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127346
Notes / Alerts

U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data

Orthopedic manual surgical instrument - Product Code LXH
Reason
Difficulty removing the cup adaptor from the impaction handle during surgery.
Action
Firm has initiated the recall by email on 04/28/2014 to all distributor's offices, including international, then followed with written communication on 05/02/2014 via Fed Ex P1 delivery to all United States consignees. Follow-up to non-responding consignees will commence 30 days after initiation.

Device

PATH(R) THREAD CUP ADAPTOR

Model / Serial
Lot Number(s): 1153896, 1279714, 1288604, and 1314793
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Manufacturer
Microport Orthopedics INC.

Manufacturer

Microport Orthopedics INC.

Manufacturer Address
Microport Orthopedics INC., 5677 Airline Rd, Arlington TN 38002-9501
Manufacturer Parent Company (2017)
Shanghai Microport Medical (Group) Co. Ltd.
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Recall of PATH(R) THREAD CUP ADAPTOR

What is this?

Device

PATH(R) THREAD CUP ADAPTOR

Manufacturer

Microport Orthopedics INC.