Z-2079-2008

Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion...

Name: Z-2079-2008 Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-03-17
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-03-17 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly... on 2005-03-17. The reason FDA records is "Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2079-2008
Status: Terminated
Initiated: 2005-03-17
Posted: 2008-09-16
Terminated: 2008-09-24
Recalling firm: Howmedica Osteonics Corp
Product: Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005
Quantity in commerce: 1 unit
Distribution: The one unit was distributed to an International Stryker branch.
Product codes and lots: Catalog No. 711-4513L; Lot Code: K04S174

Product code JWH

K962152Class IIOsteonics Scorpio Posteriorly Stabilized Total Knee SystemOsteonics Corp. / cleared 1996-08-14

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)