FDA Medical Device Recalls (openFDA)
Brainlab AG: Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
- Recall number
- Z-0959-2017
- Recalling firm
- Brainlab AG
- Product
- Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
- Status
- Terminated
- Initiated
- 2016-10-27
- Posted
- not on file
- Terminated
- 2018-04-11
- Reason
- 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
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K102990"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3002619595
- Firm city
- Munich
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28