FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics: 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.
- Recall number
- Z-0587-03
- Recalling firm
- Stryker Howmedica Osteonics
- 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.
- 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
- 136
- 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 6485-3-000 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;
- 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