CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report

VersaVit 0 Procedure Pack with Mid-Field Illuminator, Product recalled

Synergetics is recalling VersaVit 0 Procedure Pack with Mid-Field Illuminator, Product, distributed in 14 states. The recall was initiated on 11 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number M548370 (1 each or box of 6 each), exp 11/2018 Lot number M578150 (1 each or box of 6 each), exp 02/2019

Quantity recalled72 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0120-2017
FDA event ID: 74918
Recalling firm: Synergetics, O Fallon, MO
Classification: Class II
Status: Terminated
Recall initiated: 11 Aug 2016
FDA classified: 18 Oct 2016
Reported: 26 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

11 Aug 2016	Recall initiated by company
18 Oct 2016	Classified by FDA	+68 days
26 Oct 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

Where it was distributed

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.

Alabama California Indiana Kentucky Michigan Mississippi New Jersey New York Ohio South Carolina Tennessee Texas Utah Virginia

Questions about this recall

Is VersaVit 0 Procedure Pack with Mid-Field Illuminator, Product recalled?

Yes. Synergetics recalled VersaVit 0 Procedure Pack with Mid-Field Illuminator, Product on 11 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-0120-2017.

Why was it recalled?

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

Which lots are affected?

Lot number M548370 (1 each or box of 6 each), exp 11/2018 Lot number M578150 (1 each or box of 6 each), exp 02/2019

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Synergetics

All 37

Reported	Class	Recall	Company	Reason	Where
17 Jul 2024Device	CLASS I	Bausch+Lomb, I-pack Injection Kit Custom recalled by Synergetics	Synergetics	Sterility	Nationwide
17 Jul 2024Device	CLASS I	Bausch+Lomb, I-pack Injection Kit with Wire Speculum recalled	Synergetics	Sterility	Nationwide
17 Jul 2024Device	CLASS I	Bausch+Lomb, I-pack Injection Kit with Drape recalled by Synergetics	Synergetics	Sterility	Nationwide
17 Jul 2024Device	CLASS I	Bausch+Lomb, I-pack Injection Kit recalled by Synergetics	Synergetics	Sterility	Nationwide
26 Oct 2016Device	CLASS II	VersaVit 0 Vitrectomy Cutter, Product recalled by Synergetics	Synergetics	Packaging Defects	14 states

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