🔍 RecallPedia

Z1 Femoral Hip System, Product Number 611777612

Class I - Dangerous
🏥 Medical Devices Recalled: February 12, 2025 Zimmer Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277
  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:
Zimmer, Inc.
Reason for Recall:
There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Z1 Femoral Hip System, Product Number 611777612

Product Codes/Lot Numbers:

UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1329-2025

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Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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