🔍 RecallPedia

Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

Class I - Dangerous
🏥 Medical Devices Recalled: February 20, 2017 Signal Medical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All units in distribution
  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:
Signal Medical Corporation
Reason for Recall:
Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

Product Codes/Lot Numbers:

All units in distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1834-2017

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