Tibial Tray, component of Ortho Development Balanced Knee… recallZ-1993-2009 · Ortho Development Corporation · initiated May 29, 2009
Terminated All recalls posted in September 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho Development Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Mixed-up of materials/components
What the company is doing
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.
Recall details
- Recall number
- Z-1993-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 29, 2009
- Posted by the FDA
- Sep 9, 2009
- Recalling firm
- Ortho Development Corporation
- Quantity
- 13 units
- Product code
- JWH
- FDA submissions
- K994370
- Distribution
- Worldwide -- US (states of FL and TX) and Japan.
Product description
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.
Code information (models, lots, serial numbers)
Lot Number 0054891.
Other devices under the same FDA submission
4 devices cleared under K994370 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Balanced Knee System 162-1400AOrtho Development Corporation · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Balanced Knee System 161-1402Ortho Development Corporation · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Balanced Knee System 163-1509Ortho Development Corporation · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Balanced Knee System 162-1300AOrtho Development Corporation · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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