CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Femoral and Tibial Cutting Block Adapter Base recalled by Brainlab AG

Brainlab is recalling Femoral and Tibial Cutting Block Adapter Base, distributed in District of Columbia, New York, Oklahoma, Wisconsin. The recall was initiated on 27 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/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

Quantity recalled29 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0959-2017
FDA event ID: 75548
Recalling firm: Brainlab, Munich
Classification: Class II
Status: Terminated
Recall initiated: 27 Oct 2016
FDA classified: 6 Jan 2017
Reported: 18 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

27 Oct 2016	Recall initiated by company
6 Jan 2017	Classified by FDA	+71 days
18 Jan 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Where it was distributed

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.

District of Columbia New York Oklahoma Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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