Synergetics Inc: Medical Device Recall in 2016 - (Recall #: Z-0119-2017)

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 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

Product Classification:

Class II

Date Initiated: August 11, 2016

Date Posted: October 26, 2016

Recall Number: Z-0119-2017

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: 72 units

Code Information:

Lot number M545040 (1 each or box of 6 each), exp 10/2018 Lot number M586070 (1 each or box of 6 each), exp 03/2019

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