🔍 RecallPedia

25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.

Class I - Dangerous
🏥 Medical Devices Recalled: August 11, 2016 Synergetics Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot number M546500 (1 each or box of 6 each), exp 10/2018
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Synergetics Inc
Reason for Recall:
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.

Product Codes/Lot Numbers:

Lot number M546500 (1 each or box of 6 each), exp 10/2018

Distribution:

Distributed in: KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, UT, UK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0122-2017

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