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.
- Company
- Wright Medical Technology Inc
- Recall Initiated
- April 5, 2012
- Posted
- May 2, 2012
- Terminated
- January 28, 2013
- Recall Number
- Z-1485-2012
- Quantity
- 133 units
- Firm Location
- Arlington, TN
Reason for Recall
The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
Distribution
Worldwide Distribution-USA (nationwide) and the country of Australia.
Lot / Code Info
all lots distributed until 03/9/2012
Root Cause
Device Design
Action Taken
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.
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