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U.S. Department of Health and Human Services

Class 2 Device Recall Ziemer Femto LDV ZGeneration Femtosecond Surgical Lasers

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 Class 2 Device Recall Ziemer Femto LDV ZGeneration Femtosecond Surgical Laserssee related information
Date Initiated by FirmDecember 18, 2014
Date PostedJanuary 15, 2015
Recall Status1 Terminated 3 on February 20, 2018
Recall NumberZ-0988-2015
Recall Event ID 70024
510(K)NumberK131207 
Product Classification Laser, ophthalmic - Product Code HQF
ProductFemto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Code Information Serial Numbers: FLM4184, FLM2003, FLM3324, FLM1409, FLM2906, FLM2136, FLM4948, FLM3134, FLM4587, FLM3281, FLM2179, FLM1467, FLM1239, FLM3361, FLM3319, FLM3685, FLM2915, FLM1230, FLM3229, FLM4094, FLM4135, FLM4545, FLM4905, FLM3913, FLM1680, FLM1776
Recalling Firm/
Manufacturer		 Ziemer Usa Inc
620 East Third Street
Alton IL 62002
For Additional Information ContactMs. Angela Braida
618-462-9301
Manufacturer Reason
for Recall		The devices were not shipped with the Starter Kits.
FDA Determined
Cause 2		Labeling False and Misleading
ActionNotification letters dated December 18, 2014 were sent to all direct account s(customers). The letters were included with the Starter Kit referred to in the Surgical Procedure Manual.
Quantity in Commerce26 lasers
DistributionUS: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HQF
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