Wright Medical Technology Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Wright Medical Technology Inc
Lot Codes / Batch Numbers
Lot Number: 681644
Products Sold
Lot Number: 681644
Wright Medical Technology Inc is recalling ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, ST due to The left medial pivot and right medial pivot inserts were co-mingled. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The left medial pivot and right medial pivot inserts were co-mingled
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026