Date Initiated by Firm |
April 30, 2014 |
Date Posted |
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.
|