🔍 RecallPedia

CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511

Class I - Dangerous
🏥 Medical Devices Recalled: June 21, 2018 DePuy Orthopaedics Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    5307603 5300997
  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:
DePuy Orthopaedics, Inc.
Reason for Recall:
Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511

Product Codes/Lot Numbers:

5307603 5300997

Distribution:

Distributed in: AL, CA, CO, GA, IL, LA, ME, NC, NH, NY, OR, TX, UT, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2521-2018

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