25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS r
FDA device recall Z-0121-2017 · posted 2016-10-18 · Terminated
Recall details
- Recalling firm
- Synergetics Inc
- Reason for recall
- Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HQE
- Quantity affected
- 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.
- Date initiated
- 2016-08-11
- Date posted
- 2016-10-18
- Date terminated
- 2017-04-27
- Location
- O Fallon, MO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERSAVIT (K121675) | Synergetics, Inc. | 2012-06-21 |