Z-0587-03

Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and...

Name: Z-0587-03 Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and...
Creator: Stryker Howmedica Osteonics
Published: 2003-01-07
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2003-01-07 / Terminated

FDA source

Stryker Howmedica Osteonics began a recall of Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating... on 2003-01-07. The reason FDA records is "Some components have disassociated post-operatively resulting in additional surgery to the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0587-03
Status: Terminated
Initiated: 2003-01-07
Posted: 2003-02-27
Terminated: 2003-07-31
Recalling firm: Howmedica Osteonics Corp
Product: Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and stem components.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Some components have disassociated post-operatively resulting in additional surgery to the patient.
FDA root cause: Other
Action: Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.
Quantity in commerce: 136
Distribution: The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.
Product codes and lots: Catalog No. Lot No. Description 6485-3-000 D6MR MRS SML FEM STEM 10 X 102; 6485-3-011 D6CEB MRS 11MM X 127MM FEMORAL STEM; 6485-3-013 D6CFB MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6CFG MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6CFE MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6GZE MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6GZC MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAB MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAC MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAD MRS 13MM X 127MM FEMORAL STEM; 6485-3-015 D6CHD MRS 15MM X 127MM FEMORAL STEM; 6485-3-017 D6BZC MRS 17MM X 127MM FEMORAL STEM; 6485-3-017 D6GPA MRS 17MM X 127MM FEMORAL STEM; 6485-3-017 D6GPD MRS 17MM X 127MM FEMORAL STEM; 6485-3-311 D6CAB MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6CAA MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6GTA MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6GTB MRS 11MM X 203MM FEMORAL STEM; 6485-3-313 D6CBC MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6CBD MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6CBB MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6GWB MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6GWC MRS 13MM X 203MM FEMORAL STEM; 6485-3-317 D6GM MRS 17MM X 203MM FEMORAL STEM; 6485-6-409 D6HMA MRS 9MM TIBIAL STEM; 6485-6-411 D5XWB MRS 11MM TIBIAL STEM; 6485-6-411 D6HNA MRS 11MM TIBIAL STEM;

Product code JDI

K952970Class IIHowmedica Femoral & Proximal Tibial Modular Replacement SytesmHowmedica Corp. / 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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)