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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 Recall
PATH(R) THREAD CUP ADAPTOR
see related information
Date Posted June 04, 2014
Recall Status1 Open
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, Tennessee 38002-9501
Manufacturer Reason
for Recall
Difficulty removing the cup adaptor from the impaction handle during surgery
FDA Determined
Cause 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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