🔍 RecallPedia

Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component

Class I - Dangerous
🏥 Medical Devices Recalled: September 5, 2025 Exactech Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001
  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:
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component

Product Codes/Lot Numbers:

Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001

Distribution:

Distributed in: SC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0537-2026

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