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)
Recall
- Recall Number
- Z-1215-2015
- Event Number
- 70291
- Firm
- Brainlab AG Kapellenstrasse 12 Feldkirchen Germany
- FEI Number
- 3002619595
- Product Code
- OLO
- Status
- Terminated
- Root Cause
- Reprocessing Controls
- Initiated
- January 16, 2015
- Posted
- February 26, 2015
- Terminated
- March 13, 2017
Description
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)
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
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].
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
114 offset cup impactors