AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 02070051, 04070030, 0800152, 06070018, 0801863, 0802225, 0802469, 0900838, 0901751, 0902145, 0902956, 1000003, 1001504, 1004620, 1101301, 1101802, 1103359, 1104032, 1104976, 1200616, and 1202282
  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:
BioHorizons Implant Systems Inc
Reason for Recall:
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Product Codes/Lot Numbers:

Lot Numbers: 02070051, 04070030, 0800152, 06070018, 0801863, 0802225, 0802469, 0900838, 0901751, 0902145, 0902956, 1000003, 1001504, 1004620, 1101301, 1101802, 1103359, 1104032, 1104976, 1200616, and 1202282

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0561-2013

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