Recall Z-1292-2023— Brainlab AG

Name: FDA recall Z-1292-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-02

Class II · Ongoing

Class II FDA medical device recall by Brainlab AG, initiated 2023-03-02. It names one FDA 510(k) clearance: K222966. Product: Cirq Arm System 2.0. Reason: Risk of mechanical instability due to potential manufacturing error of the device.

Recalling firm: Brainlab AG
Classification: Class II
Status: Ongoing
Initiated: 2023-03-02
Firm location: Munich, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K222966 — Cirq Arm System (2.0); Alignment System SpineBrainlab AG·cleared 2022-10-27

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

Cirq Arm System 2.0

Reason for recall

Risk of mechanical instability due to potential manufacturing error of the device

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