Recall Z-1218-2017— Aesculap Implant Systems LLC

Name: FDA recall Z-1218-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-09

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2017-01-09, terminated 2017-06-14. It names one FDA 510(k) clearance: K151858. Product: GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories. Reason: Generators may have a faulty component which could impact the proper functioning of the device..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2017-01-09
Terminated: 2017-06-14
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K151858 — Caiman Seal and Cut TechnologyAesculap, Inc.·cleared 2015-07-21

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

GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories

Reason for recall

Generators may have a faulty component which could impact the proper functioning of the device.

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