🔍 RecallPedia

Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation

Class I - Dangerous
🏥 Medical Devices Recalled: September 23, 2015 Exactech Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.
  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:
Exactech, Inc.
Reason for Recall:
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation

Product Codes/Lot Numbers:

Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.

Distribution:

Distributed in: US, AZ, CO, FL, MD

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0201-2016

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