FDA Device recall Z-0119-2017
25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barr…
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II 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 barr… by Synergetics, citing vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0119-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-11 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synergetics |
| Distribution | AL, CA, IN, KY, MI, MS, NJ, NY, OH, SC, TN, TX, UT, VA |
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.
Reason
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0119-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.