PlainRecalls
FDA Devices Moderate Class II Terminated

BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655

Reported: August 19, 2020 Initiated: July 16, 2020 #Z-2793-2020

Product Description

BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655

Reason for Recall

Incorrect manufacturer calibration

Details

Recalling Firm
Brainlab AG
Units Affected
9 unit
Distribution
USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain
Location
Munich, N/A

Frequently Asked Questions

What product was recalled?
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655. Recalled by Brainlab AG. Units affected: 9 unit.
Why was this product recalled?
Incorrect manufacturer calibration
Which agency issued this recall?
This recall was issued by the FDA Devices on August 19, 2020. Severity: Moderate. Recall number: Z-2793-2020.