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.
FDA Recall Z-2294-2008 · Posted 2008-09-16
Advertisement
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeHAW
Date Initiated2008-06-05
Date Terminated2009-12-01
Product Quantity28,861 boxes of all products.
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.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement