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U.S. Department of Health and Human Services

Class 2 Device Recall VersaVit

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  Class 2 Device Recall VersaVit see related information
Date Initiated by Firm August 11, 2016
Date Posted October 18, 2016
Recall Status1 Terminated 3 on April 27, 2017
Recall Number Z-0120-2017
Recall Event ID 74918
510(K)Number K121675  
Product Classification Instrument, vitreous aspiration and cutting, ac-powered - Product Code HQE
Product 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Code Information Lot number M548370 (1 each or box of 6 each), exp 11/2018 Lot number M578150 (1 each or box of 6 each), exp 02/2019
Recalling Firm/
Synergetics Inc
3845 Corporate Centre Dr
O Fallon MO 63368-8678
For Additional Information Contact Steve Puljak
Manufacturer Reason
for Recall
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
FDA Determined
Cause 2
Action A customer notification letter was sent out on 8/11/2016 to the hospital/surgical center level. Customers were asked to fill out and return a recall acknowledgment form and send back any affected devices.
Quantity in Commerce 72 units
Distribution Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HQE and Original Applicant = SYNERGETICS, INC