Stryker Ortholock, Stryker, Kalamazoo, MI; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a tracker intended for patient tracking during computer aided orthopaedic and trauma applications.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- June 5, 2008
- Posted
- September 16, 2008
- Terminated
- December 1, 2009
- Recall Number
- Z-2294-2008
- Quantity
- 28,861 boxes of all products.
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All units distributed prior to 6/5/08.
Root Cause
Labeling False and Misleading
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.