🔍 RecallPedia

MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.

Class I - Dangerous
🏥 Medical Devices Recalled: September 19, 2014 Orthohelix Surgical Designs Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Part Number: MFT-074-CC-24; Lot: 3164011
  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:
Orthohelix Surgical Designs Inc
Reason for Recall:
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.

Product Codes/Lot Numbers:

Part Number: MFT-074-CC-24; Lot: 3164011

Distribution:

Distributed in: WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, PA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0062-2015

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