🔍 RecallPedia

MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.

Class I - Dangerous
🏥 Medical Devices Recalled: September 29, 2015 Biomet Spine Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    P/N: 14-521550; Lot Numbers: 463870; P/N: 14-521548; Lot Numbers: J86056; P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550
  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:
Biomet Spine, LLC
Reason for Recall:
The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.

Product Codes/Lot Numbers:

P/N: 14-521550; Lot Numbers: 463870; P/N: 14-521548; Lot Numbers: J86056; P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550

Distribution:

Distributed in: US, NY, MO, FL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0203-2016

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