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U.S. Department of Health and Human Services

Class 2 Device Recall Brainlab AG

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  Class 2 Device Recall Brainlab AG see related information
Date Initiated by Firm January 16, 2015
Date Posted February 26, 2015
Recall Status1 Terminated 3 on March 13, 2017
Recall Number Z-1215-2015
Recall Event ID 70291
510(K)Number K122011  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
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)
Code Information 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.
Recalling Firm/
Manufacturer		 Brainlab AG
Kapellenstrasse 12
Feldkirchen Germany
For Additional Information Contact
800-5975911
Manufacturer Reason
for Recall		 The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
FDA Determined
Cause 2		 Reprocessing Controls
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 us.support@brainlab.com.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = BRAINLAB AG
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