—#71994

Product

Stryker Ortholock EX Pin for use with the Stryker Navigation System, 3 mm x 110 mm, Stryker, Kalamazoo, MI; Part 6007-103-110. Stryker Navigation Pin for use with the Stryker Navigation System is used for trauma and orthopedic applications, e.g. hip and knee modules.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K022365, K022579
Affected lot / code info: All units distributed prior to 6/5/08.

Why it was recalled

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 (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Portage, Michigan 49002-9704

Distribution

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.

Timeline

Recall initiated: 2008-06-05
Posted by FDA: 2008-09-16
Terminated: 2009-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71994. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.