FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics: Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem
- Recall number
- Z-0588-03
- Recalling firm
- Stryker Howmedica Osteonics
- Product
- Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem
- Status
- Terminated
- Initiated
- 2003-01-07
- Posted
- 2003-02-27
- Terminated
- 2003-07-31
- Reason
- Some components have disassociated post-operatively resulting in additional surgery to the patient.
- 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
- 311
- Distribution
- The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K952970"]
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28