Recall Z-1485-2012 ยท HSB Rod, Fixation, Intramedullary And Accessories
Wright Medical Technology Inc
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 Necrosi
| Date | May 2, 2012 (initiated Apr 5, 2012) |
| Status | Terminated |
| Reason | The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage. |
| Root cause | Device Design |
| 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. |
| Quantity | 133 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090857 | VALOR ANKLE FUSION NAIL SYSTEM Wrightmedicaltechnologyinc, Jul 14, 2009 |