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 Recall Z-1637-2010 · Posted 2010-05-21
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Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-11-24
Date Terminated2010-10-21
Product Quantity47 units
Reason for Recall
The left medial pivot and right medial pivot inserts were co-mingled
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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