Z-1229-2010

5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The device is a component...

Name: Z-1229-2010 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The device is a component...
Creator: Ortho Development Corporation
Published: 2009-03-19
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2009-03-19 / Terminated / root cause: design

FDA source

Ortho Development Corporation began a recall of 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balanced Knee Modular Tibial System and is... on 2009-03-19. The reason FDA records is "A component of knee prosthesis was assembled incorrectly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1229-2010
Status: Terminated
Initiated: 2009-03-19
Posted: 2010-04-05
Terminated: 2010-06-30
Recalling firm: Ortho Development Corp.
Product: 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from severe knee pain and disability. The indications for use are: 1) loss of joint configuration and joint function, 2) Osteoarthritis of the knee joint, 3) Rheumatoid arthritis of the knee joint, 4) Post-traumatic arthritis of the knee joint, 5) Moderate valgus, varus, or flexion deformities and 6) Revision procedures where other treatments or devices have failed.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: A component of knee prosthesis was assembled incorrectly.
Root cause tag: design
FDA root cause: Device Design
Action: E-mail was sent to all agents and distributors on March 19, 2009 with illustrations and instructions on how to detect the upside down assembly and how to correct the problem if detected during surgery. Direct questions to the Ortho Development Corporation by calling 1-801-619-3444.
Quantity in commerce: 368 units
Distribution: United States (AZ, FL, OR, TX and UT) and Japan.
Product codes and lots: Serial Numbers: 567-5101; 567-5102; 567-5103; 567-5104; 567-5105; 567-5106; 567-5201; 567-5202; 567-5203; 567-5204; 567-5205 and 567-5206.

Product code JWH

K031201Class IIOrtho Development Balanced Knee Modular Tibial SystemOrtho Development Corp. / cleared 2003-07-15

MDM coverage of this record lists here, newest first.

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)