Brainlab AG recalls The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localizatio…

Recall date

January 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1215-2015

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

Worldwide Distribution - US: Nationwide (AZ, CA, ID, IL, MD, MI, MN, OH, OK, OR, TN, WA, WI, WV); Australia, Austria, Bahrain, Belgium, Germany, Hong Kong, India, Italy, Japan, Malaysia, Russian Federation, Saudi Arabia, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom

Why it was recalled

The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)