Synergetics Inc recalls 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration

Recalled October 26, 2016 · FDA recall Z-0122-2017 · Synergetics

Hazard

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

Units

9 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 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.

Manufacturer(s)

Synergetics Inc

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