Recall Z-1215-2015— Brainlab AG

Name: FDA recall Z-1215-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-16

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2015-01-16, terminated 2017-03-13. It names one FDA 510(k) clearance: K122011. Product: The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument). Reason: The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level..

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2015-01-16
Terminated: 2017-03-13
Firm location: Feldkirchen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K122011 — NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAPBrainlab AG·cleared 2012-11-15

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

The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)

Reason for recall

The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.

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