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

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

Code information: Lot number M546500 (1 each or box of 6 each), exp 10/2018

Distribution pattern: 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.