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U.S. Department of Health and Human Services

Class 2 Device Recall VALOR(R) Nail, Right, Medium

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  Class 2 Device Recall VALOR(R) Nail, Right, Medium see related information
Date Initiated by Firm March 14, 2018
Create Date April 13, 2018
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-1375-2018
Recall Event ID 79581
510(K)Number K090857  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
Code Information Lot 1608296
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
11576 Memphis Arlington Rd
Arlington TN 38002-9497
For Additional Information Contact
901-867-9971
Manufacturer Reason
for Recall		 Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
FDA Determined
Cause 2		 Under Investigation by firm
Action Firm initiated the recall on 03/14/2018 by email communication to distribution centers and distributor consignees, along with a field note to all sales representatives. The firm requested return of the product.
Quantity in Commerce 47 units
Distribution US and Argentina, Belgium, Brazil, Chile, Colombia, Germany, Italy, Mexico, Peru, Thailand, and United Kingdom
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.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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