Recall Z-0959-2017— Brainlab AG
Class II · Terminated
Class II FDA medical device recall by Brainlab AG, initiated 2016-10-27, terminated 2018-04-11. It names one FDA 510(k) clearance: K102990. Product: Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic. 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.
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-27
- Terminated
- 2018-04-11
- Firm location
- Munich, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.