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)
FDA Recall Z-1215-2015 · Posted 2015-02-26
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Recalling FirmBrainlab AG
Recall StatusTerminated
Product CodeOLO
Date Initiated2015-01-16
Date Terminated2017-03-13
Product Quantity114 offset cup impactors
Reason for Recall
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Firm Action
FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated December 11, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to utilize the sterilization cycles included in the letter. Customers were further advised to alert users of these devices to the sterilization process changes. Customers with questions can contact Brainlab by telephone at 800-597-5911 or via e-mail at [email protected].
Root Cause
Reprocessing Controls
Distribution Pattern
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
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.
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