Ortho Development Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Ortho Development Corporation
Lot Codes / Batch Numbers
Lot Number 0054891.
Products Sold
Lot Number 0054891.
Ortho Development Corporation is recalling Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF due to 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).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
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 noticeDistribution
As reported by FDA
FL, TX
Page updated: Jan 10, 2026