Z-1141-2010

Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France)

Name: Z-1141-2010 Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France)
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-08-20
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-08-20 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ on 2007-08-20. The reason FDA records is "A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right". 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-1141-2010
Status: Terminated
Initiated: 2007-08-20
Posted: 2010-03-16
Terminated: 2010-03-16
Recalling firm: Howmedica Osteonics Corp
Product: Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007.
Quantity in commerce: 4 units
Distribution: Product went to 2 US Stryker branches.
Product codes and lots: Product Code: 814407R; Lot Code: L65MKD

Product code JWH

K030978Class IIScorpio Nrg Knee SystemHowmedica Osteonics Corp. / cleared 2003-11-20

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)