Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability.
FDA Recall Z-1993-2009 · Posted 2009-09-09
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Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-05-29
Date Terminated2010-05-11
Product Quantity13 units
Reason for Recall
Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891).
Firm Action
Consignees were notified via e-mail on May 29, 2009 and June 5, 2009 requesting return of units. Direct questions about the recall to the Ortho Development Corporation by calling 1-801-619-3450.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide -- US (states of FL and TX) 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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