Z-0664-2009

Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439

Name: Z-0664-2009 Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439
Creator: Stelkast Co
Published: 2008-10-07
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2008-10-07 / Terminated / root cause: packaging

FDA source

Stelkast Co began a recall of Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439 on 2008-10-07. The reason FDA records is "Sterility may be compromised due to breach in packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0664-2009
Status: Terminated
Initiated: 2008-10-07
Posted: 2009-01-28
Terminated: 2009-04-01
Recalling firm: Globus Medical, Inc.
Product: Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439
Product code: LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: Sterility may be compromised due to breach in packaging.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On 10/7/08, Stelkast telephoned the two customers of the problem and the need to return the products.
Quantity in commerce: 6 units
Distribution: USA distribution to dealers in TX and WV.
Product codes and lots: Part number SC1439-1000. Lot number 17877-071707 exp 7/2017

Product code LWJ

K953268Class IIDual Taper Wedge Pressed Fit Femoral ComponentStelkast Company / cleared 1996-01-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)