Synergetics Inc: Medical Device Recall in 2016 - (Recall #: Z-0121-2017)

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 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, 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-0121-2017

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: 255 units

Code Information:

Lot number M543990 (1 each or box of 6 each), exp 10/2018 Lot number M545780 (1 each or box of 6 each), exp 10/2018 Lot number M569020 (1 each or box of 6 each), exp 01/2019 Lot number M578140 (1 each or box of 6 each), exp 02/2019

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