Z-0496-05

Proven Porous CR Femur. Implantable orthopedic device

Name: Z-0496-05 Proven Porous CR Femur. Implantable orthopedic device
Creator: Stelkast Co
Published: 2004-09-24
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2004-09-24 / Terminated / root cause: packaging

FDA source

Stelkast Co began a recall of Proven Porous CR Femur. Implantable orthopedic device on 2004-09-24. The reason FDA records is "Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch". 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-0496-05
Status: Terminated
Initiated: 2004-09-24
Posted: 2005-02-03
Terminated: 2005-02-07
Recalling firm: Globus Medical, Inc.
Product: Proven Porous CR Femur. Implantable orthopedic device
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm telephoned their customers 9/24/04 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm sent fax notifications to their customers. The medical supply companies were instructed to contact their customers.
Quantity in commerce: 105 units
Distribution: The product was shipped to medical supply companies in CA, MO, NC, and WV and sales representatives in AZ , NC and PA.
Product codes and lots: Catalog number SC2113-2 Lot number 3763-012501, Catalog number SC2113-3 Lot number 3764-012501, Catalog number SC2113-4 Lot number 3765-012501, Catalog number SC2113-1 Lot number 3762-012501, Catalog number SC2113-6 Lot number 3767-012501, Catalog number SC2113-5 Lot number 3766-012501, Catalog number SC2114-4 Lot number 3771-012501, Catalog number SC2114-3 Lot number 3770-012501, Catalog number SC2114-1 Lot number 3768-012501, Catalog number SC2114-2 Lot number 3769-012501, Catalog number SC2114-6 Lot number 3773-012501, and Catalog number SC2114-5 Lot number 3772-012501.

Product code JWH

K002281Class IIStelkast Proven Knee SystemStelkast Company / cleared 2000-08-17

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)