FDA Medical Device Recalls (openFDA)
Synergetics Inc: 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
- Recall number
- Z-0122-2017
- Recalling firm
- Synergetics Inc
- Product
- 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
- Status
- Terminated
- Initiated
- 2016-08-11
- Posted
- 2016-10-18
- Terminated
- 2017-04-27
- 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
- 9 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.
- Lot, serial or model codes
- Lot number M546500 (1 each or box of 6 each), exp 10/2018
- 510(k) numbers
- ["K121675"]
- PMA numbers
- not on file
- Product code
- HQE
- Firm FEI
- 1000119053
- Firm city
- O Fallon
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28