Z-1993-2009

Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300...

Name: Z-1993-2009 Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300...
Creator: Ortho Development Corporation
Published: 2009-05-29
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2009-05-29 / Terminated

FDA source

Ortho Development Corporation began a recall of Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. The... on 2009-05-29. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1993-2009
Status: Terminated
Initiated: 2009-05-29
Posted: 2009-09-09
Terminated: 2010-05-11
Recalling firm: Ortho Development Corp.
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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).
FDA root cause: Mixed-up of materials/components
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.
Quantity in commerce: 13 units
Distribution: Worldwide -- US (states of FL and TX) and Japan.
Product codes and lots: Lot Number 0054891.

Product code JWH

K994370Class IIOrtho Development Balanced Knee SystemOrtho Development Corp. / cleared 2000-03-24

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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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)