Reported Oct 26, 2016 · Terminated

25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch…

Synergetics Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Synergetics Inc · 3845 Corporate Centre Dr · O Fallon, MO · 63368-8678

Is this the product you have?

  • 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Lot codes and dates
    • Lot number M546500 (1 each or box of 6 each)
    • exp 10/2018
Amount recalled
9 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 27, 2017 · Data as of Sep 19, 5:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.