Class 2 Device Recall VersaVit

• Date Initiated by Firm: August 11, 2016
• Date Posted: October 18, 2016
• Recall Status: Terminated on April 27, 2017
• Recall Number: Z-0119-2017
• 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 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
• Code Information: Lot number M545040 (1 each or box of 6 each), exp 10/2018 Lot number M586070 (1 each or box of 6 each), exp 03/2019
• Recalling Firm/ Manufacturer: Synergetics Inc; 3845 Corporate Centre Dr; O Fallon MO 63368-8678
• For Additional Information Contact: Steve Puljak; 314-939-5100
• Manufacturer Reason for Recall: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
• FDA Determined Cause: 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: 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