FDA recall Z-2792-2020

Product

BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011

Reason for recall

Incorrect manufacturer calibration

Distribution

USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain

Key facts

Status

Terminated

Initiation date

2020-07-16

Report date

2020-08-19

Termination date

2021-07-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Munich, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2792-2020