🔍 RecallPedia

Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

Class I - Dangerous
🏥 Medical Devices Recalled: February 13, 2017 New Era Orthopaedics Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    11125
  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:
New Era Orthopaedics, LLc
Reason for Recall:
This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

Product Codes/Lot Numbers:

11125

Distribution:

Distributed in: CO, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2604-2018