Modular Replacement System with Extra-Cortical Porous… recallZ-0588-03 · Stryker Howmedica Osteonics · initiated Jan 7, 2003

Terminated All recalls posted in February 2003

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Stryker Howmedica Osteonics or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Some components have disassociated post-operatively resulting in additional surgery to the patient.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number: Z-0588-03
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Jan 7, 2003
Posted by the FDA: Feb 27, 2003
Recalling firm: Stryker Howmedica Osteonics
Quantity: 311
Product code: JDI
FDA submissions: K952970
Distribution: The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.

Product description

Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Catalog No. Lot No. Description 6485-3-008 D6JC SMALL FEMORAL STEM SECTION 8MM X 102MM; 6485-3-011 D6CDA FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CDE FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CDF FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CEA FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-013 D6ADA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6ADB FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6ADC FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFD FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFF FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFH FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFI FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFJ FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFK FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CGA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CGF FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NJA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKB FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKC FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKD FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-015 D6CHA FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHC FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHE FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHF FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRB FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRC FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRD FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRE FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-017 D5YEF FEMORAL MODULE STEM SECTION 17MM X 127MM; 6485-3-311 D5YKAA FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-311 D5YKAB FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-311 D5YKAC FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-313 D6CBA FEMORAL MODULE 13MM X 203MM CURVED LONGSTEM; 6485-6-409 D5GBE TIBIAL MODULE STEM SECTION 9MM X 127MM; 6485-6-411 D5XWA TIBIAL MODULE STEM SECTION 11MM X 127MM.

Other devices under the same FDA submission

1 device cleared under K952970 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

MRS 6485-3-211
Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 25460).

Z-0587-03 · Terminated
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 s…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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