Stryker Navigation Pin for use with the Stryker Navigation System, 4 mm x 100 mm, Stryker, Kalamazoo, MI; Part 6007-004-
FDA device recall Z-2290-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Action taken
- Consignees were notified via letter dated 6/5/08 providing them with additional warnings and instructions for use for these products. Contact Stryker Customer Service at 1-800-800-4236, ext. 3808.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 28,861 boxes of all products.
- Distribution
- Nationwide, Austria, Australia, Brazil, Canada, China, Dubai, England, France, Germany, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Singapore, South Africa, South Korea
- Date initiated
- 2008-06-05
- Date posted
- 2008-09-16
- Date terminated
- 2009-12-01
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER NAVIGATION SYSTEM-KNEE MODULE (K022579) | Stryker Leibinger | 2003-06-02 |
| STRYKER NAVIGATION SYSTEM - HIP MODULE (K022365) | Stryker Instruments | 2003-01-22 |