Z-0371-2010

Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful...

Name: Z-0371-2010 Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful...
Creator: Stelkast Co
Published: 2009-05-05
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2009-05-05 / Terminated / root cause: manufacturing process

FDA source

Stelkast Co began a recall of Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic... on 2009-05-05. The reason FDA records is "incorrect size markings on 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-0371-2010
Status: Terminated
Initiated: 2009-05-05
Posted: 2009-11-20
Terminated: 2009-11-20
Recalling firm: Globus Medical, Inc.
Product: Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis.
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Reason for recall: incorrect size markings on component
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm telephoned the medical supply companies on 5/5-19/09 to inform them of the problem and the need to return the products. If there are questions regarding this issue, please call 1.888.273.1583.
Quantity in commerce: 20 units
Distribution: Nationwide
Product codes and lots: Lot number 20210-100108

Product code HSX

K032824Class IIStelkast Unicondylar Knee SystemStelkast Company / cleared 2003-11-13

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)