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Class 2 Device Recall VersaVit |
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Date Initiated by Firm |
August 11, 2016 |
Date Posted |
October 18, 2016 |
Recall Status1 |
Terminated 3 on April 27, 2017 |
Recall Number |
Z-0122-2017 |
Recall Event ID |
74918 |
510(K)Number |
K121675
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Product Classification |
Instrument, vitreous aspiration and cutting, ac-powered - Product Code HQE
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Product |
25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration. |
Code Information |
Lot number M546500 (1 each or box of 6 each), exp 10/2018 |
Recalling Firm/ Manufacturer |
Synergetics Inc 3845 Corporate Centre Dr O Fallon MO 63368-8678
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For Additional Information Contact |
Steve Puljak 314-939-5100
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Manufacturer Reason for Recall |
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
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FDA Determined Cause 2 |
Other |
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 |
9 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
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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.
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510(K) Database |
510(K)s with Product Code = HQE and Original Applicant = SYNERGETICS, INC
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