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.
This recall has been terminated (originally issued September 9, 2009).
- Company
- Ortho Development Corporation
- Recall Initiated
- May 29, 2009
- Posted
- September 9, 2009
- Terminated
- May 11, 2010
- Recall Number
- Z-1993-2009
- Quantity
- 13 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
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).
Distribution
Worldwide -- US (states of FL and TX) and Japan.
Lot / Code Info
Lot Number 0054891.
Root Cause
Mixed-up of materials/components
Action Taken
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.
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