Recall Z-0120-2017— Synergetics Inc
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 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, 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..
- 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 recordK-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 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
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.