🔍 RecallPedia

SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

Class I - Dangerous
🏥 Medical Devices Recalled: January 9, 2019 Implant Direct Sybron Manufacturing Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot # 109038 No affected devices distributed within the US.
  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:
Implant Direct Sybron Manufacturing LLC
Reason for Recall:
Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

Product Codes/Lot Numbers:

Lot # 109038 No affected devices distributed within the US.

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1126-2020

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