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U.S. Department of Health and Human Services

Class 2 Device Recall BrainLab knee

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  Class 2 Device Recall BrainLab knee see related information
Date Initiated by Firm October 27, 2016
Create Date October 11, 2018
Recall Status1 Terminated 3 on April 11, 2018
Recall Number Z-0959-2017
Recall Event ID 75548
510(K)Number K102990  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Code Information Model/Catalog Number: 41888-04  Description: FEM&TIB CUT BLOCK ADP "UNIVERSAL" BASE1  Model/Catalog Number:41866-77A Description: FEM&TIB CUT BLOCK ADAPTER KIT UNIV  Model/Catalog Number: 99700-43  Description: IGS INSTRUMENTATION  UDI: GTIN 04056481002626  Serial numbers/lot numbers: - 1267114001 1267114070 - 1308615001 1308615045
Recalling Firm/
Manufacturer		 Brainlab AG
Olof-Palme-Strasse 9
Munich Germany
Manufacturer Reason
for Recall		 Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The firm sent out a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter via e-mail to all affected customers describing the reason for the recall as well as actions that needed to be taken. User Corrective Action: Affected customers are asked to identify all Femoral and Tibial Cutting Block Adapter Bases with serial numbers ranging from 1267114001  1267114070 and with serial number 1308615032, and remove them from clinical use in your hospital. Affected customers are not required to return the affected devices to Brainlab. Instead they are asked to dispose them according to their local regulations. Customers will be provided with a replacement accordingly. Note regarding the serial numbers/lot numbers listed in the Field Safety Notice / Product Notification CAPA- 20160914-001734: In regard to the potentially affected serial number range 1308615001  1308615045, the Field Safety Notice / Product Notification CAPA-20160914 001734 lists only one specific serial number/lot number (1308615032), since only this specific item had actually been distributed to a customer. The remaining items were still on stock when the issue was detected and are no longer distributed by Brainlab (these potentially affected items have been blocked from distribution).
Quantity in Commerce 29 units
Distribution US Consignees located in the following states: New York, Wisconsin, Oklahoma and District of Columbia.***Foreign Conisgnees located in the following countries: Australia; Belarus; Germany; India; Japan; Malaysia; Singapore; Switzerland; United Arab Emirates and 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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