Z-1381-2008

Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial...

Name: Z-1381-2008 Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-02-08
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-02-08 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product... on 2005-02-08. The reason FDA records is "Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component". 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-1381-2008
Status: Terminated
Initiated: 2005-02-08
Posted: 2008-07-16
Terminated: 2008-07-16
Recalling firm: Howmedica Osteonics Corp
Product: Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.
Quantity in commerce: 7 units
Distribution: Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.
Product codes and lots: Lot Number: K04W966.

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)