Z-0479-2008

StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1...

Name: Z-0479-2008 StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1...
Creator: Stelkast Co
Published: 2007-10-05
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2007-10-05 / Terminated / root cause: design

FDA source

Stelkast Co began a recall of StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317 on 2007-10-05. The reason FDA records is "The screws may fracture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0479-2008
Status: Terminated
Initiated: 2007-10-05
Posted: 2008-01-23
Terminated: 2008-01-23
Recalling firm: Globus Medical, Inc.
Product: StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The screws may fracture
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm telephoned their customers on 10/5/07 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, the recalling firm issued a recall letter (Field Notification) on 10/9/07 via certified mail.
Quantity in commerce: 48 units
Distribution: Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.
Product codes and lots: Lot Numbers: 14888-122005, 16052-032706, and 18549-091807.

Product code JWH

K051976Class IIProven Revision Modular Tibial TrayStelkast Company / cleared 2005-10-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)