Recall Z-2290-2008 ยท HAW Neurological Stereotaxic Instrument
Stryker Instruments Div. of Stryker Corporation
Stryker Navigation Pin for use with the Stryker Navigation System, 4 mm x 100 mm, Stryker, Kalamazoo, MI; Part 6007-004-100. Stryker Navigation Pin for use with the Stryker Navigation System is used for trauma and orthopedic applications, e.g. hip and knee modules.
| Date | Sep 16, 2008 (initiated Jun 5, 2008) |
| Status | Terminated |
| Reason | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Root cause | Labeling False and Misleading |
| Action | 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. |
| Quantity | 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, Sweden, Switzerland and Taiwan. |
| FDA record | Open on fda.gov |