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Synergetics Inc recalls 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyv
Recalled October 26, 2016 · FDA recall Z-0119-2017 · Synergetics
Hazard
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. · FDA Class II
Units
72 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 Core Essentials Procedure Pack, Product/Part Number 70025E, 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 →