Synergetics Inc recalls 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS r

Recalled October 26, 2016 · FDA recall Z-0121-2017 · Synergetics

Hazard

Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. · FDA Class II

Units

255 units

Sold at

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.

Description

Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

Product

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.

Manufacturer(s)

Synergetics Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →