Synergetics Inc: Medical Device Recall in 2016 - (Recall #: Z-0122-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 11, 2016

Date Posted: October 26, 2016

Recall Number: Z-0122-2017

Event ID: 74918

Reason for Recall:

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

Status: Terminated

Product Quantity: 9 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated