Stryker Modular Replacement System Curved Cemented Stem; MRS 15x127 Curved Femoral Stem. Catalog Number: 6485-3-715; Str
FDA device recall Z-0926-2008 · posted 2008-02-26 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 803 total, all sizes
- Distribution
- Nationwide Distribution
- Date initiated
- 2007-11-15
- Date posted
- 2008-02-26
- Date terminated
- 2008-09-22
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM (K952970) | Howmedica Corp. | 1996-01-17 |