Recall Z-1215-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Wright Medical Technology Inc
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
| Date | Mar 31, 2010 (initiated Feb 19, 2010) |
| Status | Terminated |
| Reason | The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws). |
| Root cause | Employee error |
| Action | 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 |
| Quantity | 47 units |
| Distribution | Worldwide Distribution -- United States, Canada, Netherlands, Germany, Japan, S. Korea, UK, Czech Republic, Turkey and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973524 | ADVANCE MODULAR TIBIAL COMPONENT Wrightmedicaltechnologyinc, Dec 12, 1997 |