Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PATH(R) THREAD CUP ADAPTOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall PATH(R) THREAD CUP ADAPTORsee related information
Date Initiated by FirmApril 30, 2014
Date PostedJune 04, 2014
Recall Status1 Terminated 3 on December 01, 2014
Recall NumberZ-1712-2014
Recall Event ID 68326
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductPATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Code Information Lot Number(s): 1153896, 1279714, 1288604, and 1314793
FEI Number 3010536692
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
ActionFirm 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 Commerce140 units
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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.
-
-