🔍 RecallPedia

Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

Class I - Dangerous
🏥 Medical Devices Recalled: November 7, 2016 Exactech Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Serial No. 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, 4565752-4565760; Catalog No. 160-70-15; UDI: 10885862033086
  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:
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

Product Codes/Lot Numbers:

Serial No. 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, 4565752-4565760; Catalog No. 160-70-15; UDI: 10885862033086

Distribution:

Distributed in: AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1030-2017

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