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U.S. Department of Health and Human Services

Class 2 Device Recall PATH(R) THREAD CUP ADAPTOR

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  Class 2 Device Recall PATH(R) THREAD CUP ADAPTOR see related information
Date Initiated by Firm April 30, 2014
Date Posting Updated June 04, 2014
Recall Status1 Terminated 3 on December 01, 2014
Recall Number Z-1712-2014
Recall Event ID 68326
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Code Information Lot Number(s): 1153896, 1279714, 1288604, and 1314793
Recalling Firm/
Manufacturer
Microport Orthopedics INC.
5677 Airline Rd
Arlington TN 38002-9501
Manufacturer Reason
for Recall
Difficulty removing the cup adaptor from the impaction handle during surgery
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 140 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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