🔍 RecallPedia

Clinic Pack 100 Pieces FG 57 100057C (100057C)

Class I - Dangerous
🏥 Medical Devices Recalled: October 20, 2020 Coltene Whaledent Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    J74027
  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:
Coltene Whaledent Inc
Reason for Recall:
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Clinic Pack 100 Pieces FG 57 100057C (100057C)

Product Codes/Lot Numbers:

J74027

Distribution:

Distributed in: FL, NV, PA, TN, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0466-2021

Related Recalls

SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001

Coltene Whaledent

Class I - Dangerous

Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button

Jan 20, 2023 Other Medical Devices Nationwide View Details →