Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Recall
- Recall Number
- Z-0959-2017
- Event Number
- 75548
- Firm
- Brainlab AG Olof-Palme-Strasse 9 Munich Germany
- FEI Number
- 3002619595
- Product Code
- OLO
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- October 27, 2016
- Terminated
- April 11, 2018
Description
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
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
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).
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.
29 units