25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
This recall has been terminated (originally issued October 18, 2016).
- Company
- Synergetics Inc
- Recall Initiated
- August 11, 2016
- Posted
- October 18, 2016
- Terminated
- April 27, 2017
- Recall Number
- Z-0122-2017
- Quantity
- 9 units
- Firm Location
- O Fallon, MO
- Official Source
- View on FDA website ↗
Reason for Recall
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
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 / Code Info
Lot number M546500 (1 each or box of 6 each), exp 10/2018
Root Cause
Other
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.
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