Z-0122-2017 Class II Terminated
FDA device recall Z-0122-2017 was initiated by Synergetics Inc on August 11, 2016 and is designated Class II. Reason for recall: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. The recall status is terminated (terminated April 27, 2017). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2016
- Initiation Date
- August 11, 2016
- Termination Date
- April 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Reason for Recall
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Distribution Pattern
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.
Code Information
Lot number M546500 (1 each or box of 6 each), exp 10/2018