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U.S. Department of Health and Human Services

Class 2 Device Recall VALOR(R), TARGETING GUIDE

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 Class 2 Device Recall VALOR(R), TARGETING GUIDEsee related information
Date Initiated by FirmApril 05, 2012
Date PostedMay 02, 2012
Recall Status1 Terminated 3 on January 28, 2013
Recall NumberZ-1484-2012
Recall Event ID 61602
510(K)NumberK090857 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductVALOR(R), TARGETING GUIDE, REF 4150011000, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcots Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
Code Information all lots distributed until 03/9/2012
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information ContactCathy A.M. Park
901-867-4324
Manufacturer Reason
for Recall		The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
FDA Determined
Cause 2		Device Design
ActionWright Medical Technology, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their stock and to return the affected product to the firm. Additionally, a Product Recall Verification Form was enclosed for customers to complete and return via fax to 901-867-7401. Contact the firm at 901-867-4324 for questions regarding this notice.
Quantity in Commerce133 units
DistributionWorldwide Distribution-USA (nationwide) and the country of Australia.
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.
510(K) Database510(K)s with Product Code = HSB
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