FDA-Device2016-10-26Class II
25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Synergetics Inc
Hazard
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Sold states
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.
Affected count
9 units
Manufactured in
3845 Corporate Centre Dr, N/A, O Fallon, MO, United States
Products
25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0122-2017Don't want to check this manually?
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