Z-1637-2010

ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO...

Name: Z-1637-2010 ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO...
Creator: Wright Medical Technology Inc
Published: 2009-11-24
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2009-11-24 / Terminated / root cause: packaging

FDA source

Wright Medical Technology Inc began a recall of ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road... on 2009-11-24. The reason FDA records is "The left medial pivot and right medial pivot inserts were co-mingled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1637-2010
Status: Terminated
Initiated: 2009-11-24
Posted: 2010-05-21
Terminated: 2010-10-21
Recalling firm: Wright Medical Technology Inc
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The left medial pivot and right medial pivot inserts were co-mingled
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 47 units
Distribution: Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan.
Product codes and lots: Lot Number: 681644

Product code JWH

K972770Class IIAdvance Ultra-Congruent Tibial InsertWrightmedicaltechnologyinc / cleared 1997-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)