Synergetics Inc recalls 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Ty…

Recall date

August 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0119-2017

FDA classification

Class II

Brand / firm

Synergetics Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.