—#90854

Product

ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K972770
Affected lot / code info: Lot Number: 681644

Why it was recalled

The left medial pivot and right medial pivot inserts were co-mingled

Root cause (FDA determination)

Packaging process control

Action the firm took

Wright Medical Technology, Inc. issued an "Urgent: Medical Device Voluntary Recall" notification dated November 24, 2009. The letters were addressed to distributors, hospital administrators, and surgeons. Consignees were asked to return all affected product in addition to a completed Response Form to the firm. For further information, contact Wright Medical Technology, Inc. at 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, The Netherlands, Italy, Republic of Korea and Japan.

Timeline

Recall initiated: 2009-11-24
Posted by FDA: 2010-05-21
Terminated: 2010-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90854. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.