various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item 163005 Lot 309030
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Zimmer Biomet, Inc.
- Reason for Recall:
- Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.
Product Codes/Lot Numbers:
Item 163005 Lot 309030
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1858-2017
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