| | Class 2 Recall
VALOR(R), TARGETING GUIDE |  |
| Date Posted |
May 02, 2012 |
| Recall Number |
Z-1484-2012 |
| Product |
VALOR(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, Tennessee 38002-9501 |
| For Additional Information Contact |
Cathy A.M. Park
901-867-4324
|
Reason for
Recall |
The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
|
| 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 in Commerce |
133 units |
| Distribution |
Worldwide Distribution-USA (nationwide) and the country of Australia. |
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