VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, 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.
FDA Recall Z-1485-2012 · Posted 2012-05-02
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Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeHSB
Date Initiated2012-04-05
Date Terminated2013-01-28
Product Quantity133 units
Reason for Recall
The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
Firm Action
Wright 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the country of Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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