Z-0042-04

Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System

Name: Z-0042-04 Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System
Creator: Ortho Development Corporation
Published: 2003-09-15
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2003-09-15 / Terminated

FDA source

Ortho Development Corporation began a recall of Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System on 2003-09-15. The reason FDA records is "The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0042-04
Status: Terminated
Initiated: 2003-09-15
Posted: 2003-10-15
Terminated: 2003-12-11
Recalling firm: Ortho Development Corp.
Product: Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
FDA root cause: Other
Action: The firm has telephoned all distributors regarding the recall. An advisory note and product return request letters were sent to all distributors on 9/15/03.
Quantity in commerce: 27
Distribution: Units were sent to distributors in AZ, CA, FL, MO, OK and TX. Units were also distributed to firm's parent company in Japan.
Product codes and lots: Part # 252-0300, Lot # W007919.

Product code JWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)