FDA-Device2016-10-26Class II
25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
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
255 units
Manufactured in
3845 Corporate Centre Dr, N/A, O Fallon, MO, United States
Products
25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0121-2017Don't want to check this manually?
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