🔍 RecallPedia

DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR

Class I - Dangerous
🏥 Medical Devices Recalled: May 7, 2021 DePuy Orthopaedics Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot: D20111130 GTIN: 10603295033172
  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:
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR

Product Codes/Lot Numbers:

Lot: D20111130 GTIN: 10603295033172

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1845-2021

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