Locking Cortical Screw 3.5mmX38mm REF 8161-35-038

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
  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, Inc.
Reason for Recall:
3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Locking Cortical Screw 3.5mmX38mm REF 8161-35-038

Product Codes/Lot Numbers:

Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D

Distribution:

Distributed in: US, AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0716-2014

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