Z-0119-2017Class II

25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray...

Name: Z-0119-2017 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray...
Creator: Synergetics Inc
Published: 2016-08-11
License: https://open.fda.gov/license/

Synergetics Inc / initiated 2016-08-11 / Terminated

FDA source

Synergetics Inc began a recall of 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 on 2016-08-11. FDA classified it as Class II and gives the reason as "Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0119-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-11
Posted: 2016-10-18
Terminated: 2017-04-27
Recalling firm: Synergetics Inc
Product: 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 code: HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Reason for recall: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
FDA root cause: Other
Action: A customer notification letter was sent out on 8/11/2016 to the hospital/surgical center level. Customers were asked to fill out and return a recall acknowledgment form and send back any affected devices.
Quantity in commerce: 72 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0119-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0119-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0120-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0121-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0122-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18

Product code HQE

K121675Class IIVersavitSynergetics, Inc. / cleared 2012-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)