🔍 RecallPedia

Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes

Class I - Dangerous
🏥 Medical Devices Recalled: June 5, 2015 Cochlear Americas Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15
  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:
Cochlear Americas Inc.
Reason for Recall:
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes

Product Codes/Lot Numbers:

Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2155-2015

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