FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Modular Replacement System Curved Cemented Stem; MRS 17x127 Curved Femoral Stem. Catalog Number: 6485-3-717; Stryker Orthopaedics Mahwah, NJ 07430
- Recall number
- Z-0927-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Modular Replacement System Curved Cemented Stem; MRS 17x127 Curved Femoral Stem. Catalog Number: 6485-3-717; Stryker Orthopaedics Mahwah, NJ 07430
- Status
- Terminated
- Initiated
- 2007-11-15
- Posted
- 2008-02-26
- Terminated
- 2008-09-22
- Reason
- Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Root cause
- Process design
- Action
- On November 26, 2007, Stryker Sent Urgent Product Recall notification letters to Stryker Agencies/Branches and hospitals (OR Supervisor) by Federal Express. The notification requested that all inventory be examined and returned. Returning instructions were provided in the letter. Questions concerning this recall are being addressed by contacting the Regulatory Compliance Hotline at (201) 831-6633.
- Quantity
- 803 total, all sizes
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Catalog Number: 6485-3-717; Lot Codes: LCDCH, TEC029A, TEC057A, TEC089B, TEC089C, TEC089D, TEC089E, TEC089E2, TEC089F, TEC089G, TEC089G1, TEC089H1, TEC089I1, TEC144, TEC145, TE 259, TEC301.
- 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