Recall Z-2792-2020— Brainlab AG

Name: FDA recall Z-2792-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-16

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2020-07-16, terminated 2021-07-27. It names one FDA 510(k) clearance: K183605. Product: BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011. Reason: Incorrect manufacturer calibration.

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2020-07-16
Terminated: 2021-07-27
Firm location: Munich, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K183605 — Spine & Trauma NavigationBrainlab AG·cleared 2019-08-29

K-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

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

Reason for recall

Incorrect manufacturer calibration

Data sourced from openFDA. This site is unofficial and independent of the FDA.