ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. The device is intended for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease, 2)inflammatory joint disease, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed and 5) treatment of fractures that are unmanageable using other techniques. (For cement use only).
This recall has been terminated (originally issued March 31, 2010).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- February 19, 2010
- Posted
- March 31, 2010
- Terminated
- July 8, 2011
- Recall Number
- Z-1215-2010
- Quantity
- 47 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws).
Distribution
Worldwide Distribution -- United States, Canada, Netherlands, Germany, Japan, S. Korea, UK, Czech Republic, Turkey and Brazil.
Lot / Code Info
Lot numbers: 087441267 and 097441268.
Root Cause
Employee error
Action Taken
The firm initiated their recall of the product by letter on February 19, 2010. The notification letters were addressed to distributors, hospital administrators, and surgeons with a fax back response form. The letter described the affected product and reason for the recall. Customers were instructed to examine their inventory and return the recalled product to Wright Medical Technology, Inc. Customers may contact Customer Service by calling 1-800-238-7117 for return instructions and replacement inventory. Direct questions regarding this matter to Wright Medical Technology, Inc. by calling 1-800-874-5630.