Recall Z-0988-2015— Ziemer Usa Inc

Name: FDA recall Z-0988-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-18

Class II · Terminated

Class II FDA medical device recall by Ziemer Usa Inc, initiated 2014-12-18, terminated 2018-02-20. It names one FDA 510(k) clearance: K131207. Product: Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.. Reason: The devices were not shipped with the Starter Kits..

Recalling firm: Ziemer Usa Inc
Classification: Class II
Status: Terminated
Initiated: 2014-12-18
Terminated: 2018-02-20
Firm location: Alton, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K131207 — FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASERSurgical Instrument Engineering AG·cleared 2013-10-09

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

Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.

Reason for recall

The devices were not shipped with the Starter Kits.

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