Class II — Synergetics Inc
| Recalling firm | SYNERGETICS, INC. |
|---|---|
| Registered facility | SYNERGETICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. |
| Product | 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. |
| Quantity | 255 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. |
| Initiated | 2016-08-11 |
| Classified | 2016-10-18 |
| Terminated | 2017-04-27 |
| Recall number | Z-0121-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Synergetics Inc (Z-0121-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74918/
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