Recall Z-0122-2017— Synergetics Inc

Name: FDA recall Z-0122-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-11

Class II · Terminated

Class II FDA medical device recall by Synergetics Inc, initiated 2016-08-11, terminated 2017-04-27. It names one FDA 510(k) clearance: K121675. Product: 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.. Reason: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification..

Recalling firm: Synergetics Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-11
Terminated: 2017-04-27
Firm location: O Fallon, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K121675 — VERSAVITSynergetics, Inc.·cleared 2012-06-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.