Recall Z-1215-2015
Brainlab AG · initiated January 16, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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)
Codes / lots: Model 52856 BL CURVED CUP INSERTER UNIVERSAL SHAFT; and MODEL 52856A BL OFFSET CUP IMPACTOR UNIVERSAL SHAFT, all serial/lot numbers distributed prior to January 13, 2015.
Reason for recall
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
FDA-determined cause: Reprocessing Controls
Action taken
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 us.support@brainlab.com.
Details
- Recall number
- Z-1215-2015
- Initiated
- January 16, 2015
- Posted by FDA
- February 26, 2015
- Terminated
- March 13, 2017
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Quantity
- 114 offset cup impactors
- Distribution
- 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
- Recalling firm
- Brainlab AG, Feldkirchen