Z-0059-06

Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker...

Name: Z-0059-06 Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-08-11
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-08-11 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package on 2005-08-11. The reason FDA records is "The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0059-06
Status: Terminated
Initiated: 2005-08-11
Posted: 2005-10-15
Terminated: 2007-08-15
Recalling firm: Howmedica Osteonics Corp
Product: Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The recall notification was sent out via FedEx on 8/11/2005 with requested return receipt.
Quantity in commerce: 7 units
Distribution: The product was distributed to their sales representatives/sales agencies, hospitals, and international distribution. The product was shipped to Stryker Germany and Stryker France.
Product codes and lots: Catalog No. 70-4107R Lot code: K04W896.

Product code JWH

K974556Class IIOsteonics Scorpio Posterior Cruciate Retaining Total Knee SystemOsteonics Corp. / cleared 1998-02-27

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)