Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model 1600407 / Catalog number 1600407-001 Serial Numbers: 16C0017 16F0013 16I0009 16K0017 17F0039 17I0015 17L0013
  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:
Bien-Air Surgery Sa
Reason for Recall:
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

Product Codes/Lot Numbers:

Model 1600407 / Catalog number 1600407-001 Serial Numbers: 16C0017 16F0013 16I0009 16K0017 17F0039 17I0015 17L0013

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0176-2021

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The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

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