—#89000

Product

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).

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K973524
Affected lot / code info: Lot numbers: 087441267 and 097441268.

Why it was recalled

The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws).

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Rd, Arlington, Tennessee 38002

Distribution

Distribution pattern: Worldwide Distribution -- United States, Canada, Netherlands, Germany, Japan, S. Korea, UK, Czech Republic, Turkey and Brazil.

Timeline

Recall initiated: 2010-02-19
Posted by FDA: 2010-03-31
Terminated: 2011-07-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89000. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.