🔍 RecallPedia

APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.

Class I - Dangerous
🏥 Medical Devices Recalled: June 4, 2015 Omnilife Science Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097
  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:
Omnilife Science Inc.
Reason for Recall:
The device may have improper screw hole placement due to inaccurate location of the index line.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.

Product Codes/Lot Numbers:

H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2445-2015

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