Recall Z-0119-2017 ยท HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Synergetics Inc
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.
| Date | Oct 18, 2016 (initiated Aug 11, 2016) |
| Status | Terminated |
| Reason | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121675 | VERSAVIT Synergetics, Inc., Jun 21, 2012 |