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Brainlab AG recalls The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localizat
Recalled March 4, 2015 · FDA recall Z-1215-2015 · Brainlab AG
Hazard
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level. · FDA Class II
Units
114 offset cup impactors
Sold at
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
Description
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Product
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)
Manufacturer(s)
Brainlab AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →