—#108522

Product

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 product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K090857
Affected lot / code info: all lots distributed until 03/9/2012

Why it was recalled

The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Rd, Arlington, Tennessee 38002-9501

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the country of Australia.

Timeline

Recall initiated: 2012-04-05
Posted by FDA: 2012-05-02
Terminated: 2013-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108522. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.