FDA-Device2015-03-04Class II
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)
Brainlab AG
Hazard
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Sold states
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
Affected count
114 offset cup impactors
Manufactured in
Kapellenstrasse 12, N/A, Feldkirchen, N/A, Germany
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1215-2015Don't want to check this manually?
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